• Title/Summary/Keyword: Trial

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Bioequivalence of Boryung Torsemide Tablet to Torem Tablet (Torasemide 10 mg) by High Performance Liquid Chromatography/UV Detector

  • Cho, Hea-Young;Kang, Hyun-Ah;Park, Chan-Ho;Kim, Se-Mi;Kim, Dong-Ho;Park, Sun-Ae;Kim, Kyung-Ran;Hur, Hyeon;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.5
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    • pp.323-328
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    • 2005
  • The purpose of the present study was to evaluate the bioequivalence of two torasemide tablets, Torem tablet (Roche Korea Co., Ltd., Korea, reference drug) and Boryung Torsemide tablet (Boryung Pharmaceutical Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (furosemide) to human serum, serum samples were extracted using 5 mL of ethyl acetate. Compounds were analyzed by reverse-phase HPLC method with UV detection. This method showed linear response over the concentration range of 0.05 ug/mL with correlation coefficient of 0.999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ug/mL which was sensitive enough for pharmacokinetic studies. Twenty-eight healthy male Korean volunteers received each medicine at the torasemide dose of 20 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of torasemide were monitored by an HPLC-UV for over a period of 12 hr after the administration. $AUC_{t}$(the area under the serum concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum serum drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{t}$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_{t}$ ratio and the $C_{max}$ ratio for Boryung Torsemide/Torem were log 0.97-10g 1.03 and log 0.93log 1.12, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Boryung Torsemide tablet and Torem tablet are bioequivalent.

The Effects of Pulsator Washing Machine on Joints Torques and Muscles Strengths Considering Height of Outside Machine and Depth of Inside Drum for Average Height Users (투입구 높이 및 내부 드럼 깊이를 고려한 펄세이터 세탁기 사용시 평균신장 사용자의 관절 토크 및 근력에 미치는 영향)

  • Kim, Seong Guk;Cho, Young Kuen;Lee, Nam Gi;You, Joshua Sung Hyun;Lim, Dohyung;Kim, Han Sung;Ko, Chang-Yong
    • Journal of Biomedical Engineering Research
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    • v.33 no.4
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    • pp.184-193
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    • 2012
  • Many studies have reported that housework done using household appliances may affect biomechanical characteristics of the musculoskeletal system. The purpose of this study was to investigate the effects of housework done using a pulsator washing machine on joints and muscles. We calculated joint torques and muscle strengths on the basis of an experimental/virtual three-dimensional motion analysis for six healthy females using the pulsator washing machine at different heights (H) and depths (D) of the inside drum (H (mm){\times}D (mm), Trial1: $962.5{\times}609.4$, Trial2: $962.5{\times}624.4$, Trial3: $982.5{\times}644.4$, Trial4: $995.5{\times}642.4$, Trial5: $1015.5{\times}677.4$). The joint torques and muscle strengths tended to be considerably different during torso flexion in the sagittal plane for all the trials. The maximum joint torques for the thoracic vertebra, left ankle, and right shoulder measured in Trial4 were significantly higher than those measured in the other trials (p < 0.05); in addition, those for the thoracic vertebra and both ankles measured in Trial5 were significantly higher than those measured in the other trials (p < 0.05). The maximum muscle strengths for the left trapezius muscle and both tibialis anterior muscles measured in Trial5 were significantly higher than those measured in the other trials (p < 0.05). These results indicate that housework done using a pulsator washing machine may affect joint torques and muscle strengths, and these effects are dependent on the height and/or depth of the inside drum of the pulsator washing machine.

Induced Ovulation in rabbitfish, siganus canaliculatus, with Human chorionic Gonadotropin (HCG) (태반성 성선자극호르몬(HCG) 처리에 의한 독가시치, Siganus canaliculatus의 배란유도)

  • Hwang, Hyung-Kyu;Lee, Jung-Uie;Yang, Sang-Geun;Rho, Sum;Kang, Yong-Jin
    • Journal of Aquaculture
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    • v.12 no.3
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    • pp.197-204
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    • 1999
  • Successful produciton of seedlings for marine fish species are highly influenced by the aquisiton of sufficient number of good-quality eggs on required time. human chorionic gonadotropin has been used to induce successful ovulation for the purpose. Rabbitfish, siganus canaliculatus, is inhabited along the coast of Cheju Province and treated valuably for raw fish and fish roasted with seasoning. Female wild-captured rabbitfish (314 to 279 g in body weigth) were injected into intraperitoneal space with human chorionic gonadotropin (HCG) of 5,00,1,000, and 1,500 IU/kg body weight during spawning season of July 14 (trial 1), and July 27 (trial 2). Test fish in trial 1 were injected two times, first on July 14 and second on July 21 with one weekinterval because of no ovulation symptoms, but just one time in trial 2. All females injected both 1,000 and 1,500 IU/kg body weight ovulated in all trials. Among 500 IU/kg injection treatments, just one female ovulated in trial 1 showing 25% of ovulation rate, but none ovulated in trial 2. Ovulation was not occurred in control goups during test period. Time to reach ovulation after injection was 172 to 270 hours in trial 1 and 77 to 132 hours in trial 2, showing shorter as spawning season approached. Generally, ovulation of smaller females were late than that of larger ones. Gonadosomatic index (GSI) and pseudo-gonadosomatic index (Pseudo-GSI) were ranged 22 to 33% and 19 to 28%, respectively. One female spawned 406,200 to 1,032,000 eggs, and obtainable eggs per 100g of body weight were calculated by 130,000 to 190,000. Spawning rates were comparatively high by 96.0 to 98.4%. Rates to reach embryo-formation and hatching were higher in 500 high by 96.0 to 98.4%. Rates to reach embryo-formation and hatching were higher in 500 and 1,000 IU/kg treatments than in 1,500 IU/kg treatment. The result of present study demontrates that HCG treatment during spawning season could become very useful for ovulation of rabbitfish and the suitable dosage was suggested as 1,000 IU/kg of body weight.

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Digestive Enzymatic and Nucleic Acidic Responses of Olive Flounder Paralichthys oilivaceus Larvae Fed Cyclopoid Copepod Paracyclopina nana (기수산 Cyclopoid 요각류 Paracyclopina nana를 섭취한 넙치 Paralichthys olivaceus 자어의 핵산 함량과 소화효소적 반응)

  • Kwon, O-Nam;Lee, Kyun-Woo;Kim, Gun-Up;Park, Heum-Gi
    • Journal of Aquaculture
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    • v.21 no.3
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    • pp.190-195
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    • 2008
  • We investigated the changes in growth, digestive enzymes activities, nucleic acids contents and RNA/DNA ratio of flounder Paralichthys olivaceus larvae (C for Paracyclopina nana, A for Artemia, and M for Mix of C and A) for 14 to 28 DAH. Body length of flounder larvae showed the best in the C trial at 28 DAH. The change of nucleic acids contents showed faster in C and M trials than A trial. And RNA/DNA ratio showed the significantly faster changes in C trial than A trial. High metamorphosis rates were also observed in C and M trial. $\alpha$-amylase activities increased gradually up to 28 DAH in all trials. Total alkaline protease (TAP) activities of A trial showed the highest value to 9 mU/larvae at 26 DAH. But others trials showed lower to $5{\sim}6$ mU/larva than A trial. TAP:$\alpha$-amylase activity ratio did not significantly changed to $0.025{\sim}0.053$ in A trial during the experiments. But, C and M trials tended to gradually decrease from $0.078{\sim}0.083$ (initial) to $0.013{\sim}0.018$ (final). Therefore, it shown the ratio gradually decreased of TAP:$\alpha$-amylase activity, stability of TAP activity, and rapid change of nucleic acids in trials grown positively. Thus, because P. nana could continuously supply the optimal nutrients for flounder larvae, we suggested the supplement of the copepod to an efficient feed of the flounder larvae.

A randomized, double-blind, placebo-controlled pilot study to assess the effects of protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract on the prevention of acute respiratory illness in healthy people

  • Hwang, Jeong-Hwan;Park, Soo-Hyun;Choi, Eun-Kyung;Jung, Su-Jin;Pyo, Mi Kyung;Chae, Soo-Wan
    • Journal of Ginseng Research
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    • v.44 no.5
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    • pp.697-703
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    • 2020
  • Background: GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial. Methods: This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms. Results: The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively. Conclusion: The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.

Comparative Review of Current Clinical Trials on Abdominal Obesity (복부비만 관련 임상시험의 국내외 연구경향 고찰)

  • Lim, Je-Yeon;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine Rehabilitation
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    • v.20 no.2
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    • pp.63-77
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    • 2010
  • Objectives : It is known that abdominal obesity increases the possibility of cardiovascular diseases, early death, and metabolic syndrome including dyslipidemia and insulin resistance. Clinical trials have been under way to verify the effectiveness of treatment for abdominal obesity. The objective of this study is to set criteria about how effective oriental medicine and acupuncture are in abdominal obesity. Methods : I manually search "www.clinicaltrial.gov", 4 Korean medical databases and 4 Korean medical journals of abdominal obesity. Search terms used were "abdominal obesity" or "visceral obesity". In order to see detail review, searching was performed from 01, 01, 2005 to 11, 31, 2009. And I classified all the searched studies into design, intervention, purpose, end point, diseases, condition and etc. Results : 1. I could search total 67 trials in "www.clinicaltrial.gov". I found 9, 10, 13, 8, 6 clinical trial from 2005 to 2009 every year. 2. Test on both gender and adult or adult and senior have been most frequent. 3. Randomization clinical trial is 51 cases that occupied 96.2%. 38 cases use control group. 4. Body mass index(BMI) and waist circunference(WC) are major criteria of abdominal obesity clincal trial. WC, BMI, abdominal fat mass, body weight are measured at end point of abdominal obesity clincal trial. 5. I could search total 86 cases in domestic study. I found 15, 23, 23, 20, 5 cases from 2005 to 2009 every year. 6. Test on female and adult have been most frequent in domestic study. 7. Randomization clincal trial is only 2 cases that occupied 2.3%. 62 cases use control group in domestic study. 8. BMI, body fat percent, WC, visceral-subcutaneous fat ratio(VSR), waist-hip ratio(WHR) are criteria of abdominal obesity clincal trial in domestic study. WC, BMI, abdominal fat mass, body weight are measured at end point of abdominal obesity clincal trial in domestic study. Conclusions : To improve abdominal obesity study in traditional korean medicine, it is need to activate clinical trial, meta analysis, develope of clinical practice guidelines, co-works with conventional medicine and etc.

An Evaluation on Quality of Field Trial Protocol using Pay Factor and Analysis of Fatigue Life (지불계수를 이용한 시험포장구간의 품질평가와 피로수명 분석)

  • Lee, Jae-Hack;Rhee, Suk-Keun;Kim, Seong-Min;Hwang, Sang-Min
    • International Journal of Highway Engineering
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    • v.11 no.4
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    • pp.133-142
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    • 2009
  • This research is performed to estimate quality of trial pavement for construction and analyze effect of fatigue life by using the pay factor. Specially, asphalt content which is difficult to control the pavement quality, is selected by pay adjustment standard factors and pay factor is calculated by asphalt content. This research is also analyzed to present relation of fatigue life according to asphalt content, to evaluate quality of the road pavement by calculating pay factor of sampling trial field mixture 2 times. This research confirms that it is different quality of road pavement according to pay factor changes. To analyze the fatigue life of pavement by using asphalt mixture for trial field. As a result, it is conformed that high pay factor could be high fatigue life of trial field. This means that pay factor using probability theory reflects road pavement fatigue life. Also, this study is included that beam fatigue test manufacturing specimen such as mixing type of plant which purvey asphalt mixture to trial field, compared with fatigue life of trial field. As a result, the fatigue life of specimen that is manufactured by mix type is higher than trial field specimen. This means that performance of road pavement can be reduced by gradation or other effects. Therefore, to exactly evaluate the quality of road pavement, pay factor should be calculated appling various pay adjustment standard factors such as gradation, air-void in U.S. states which is adopted pay adjustment.

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The Actual Management State of Trial Contact Lenses and Lens Care Products in Local Optical Shops (안경원의 시험착용 콘택트렌즈 및 관리용품 관리 실태)

  • Park, Mijung;Lee, Unjung;Kim, So Ra
    • Journal of Korean Ophthalmic Optics Society
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    • v.16 no.4
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    • pp.391-401
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    • 2011
  • Purpose: In the present study, the actual management state of trial contact lenses and lens care products in local optical shops was surveyed and analyzed to reduce the risk of lens complication possibly induced by neglecting lens care. Methods: The feeling of contact lens wearers during the wear of trial contact lenses was surveyed. Futhermore, the actual management state of trial contact lenses such as cosmetic lens and RGP lens and lens care products was also investigated by surveying opticians who trade contact lenses in local optical shops. Results: It was found that consumers trusted the sanitary conditions of the lens since trial cosmetic contact lens and RGP lens were cleaned before and after trails by over 98% of opticians in local optical shops. For trial cosmetic lens, cleaning with normal saline, multipurpose solution for soft lens and combination of saline and multipurpose solution were 38.5%, 40.5% and 21%, respectively, before trials. After trials, cosmetic lenses were cleaned with normal saline, multipurpose solution for soft lens and a combination of saline and multipurpose solution were 13%, 75%, and 12%, respectively. On the other hand, cleaning with normal saline, multipurpose solution for RGP lens and combination of saline and multipurpose solution were 28.5%, 38.5% and 33%, respectively, before trying trial RGP lens. After trials, RGP lenses were cleaned with normal saline, multipurpose solution for RGP lens and a combination of saline and multipurpose solution were 2.5%, 70%, and 27.5%, respectively, indicating that relatively many opticians followed the lens cleaning regimen. In local optical shops, the cleaning trial cosmetic lens was mainly conducted at every 10 days or a month and the washing cycle of cosmetic lens case was in a month or 2~3 months. The cleaning interval of trial RGP lens was primarily in a month or 2~3 months. For those lens cases, more than 75% of opticians washed them with a surfactant and then rinsed with cold water. The storing periods of lens care products were primarily in a week for saline and in a month and 2~3 months indicating that storing period of lens care products was relatively well-kept in local optical shops. Conclusions: It is thought that the concern about any microbial infection is not that high since trial contact lenses and lens care products were generally well-managed by opticians in local optical shops from the results above. However, better public eye health and better public confidence in opticians may be possible if further strengthen in avoidance of lens cleaning with saline, keep of cleaning cycles within 2 weeks and rinsing of lens cases with hot water happens.

An Analysis on the Knowledge Levels, Attitudes, and Factors Affecting the Choices of Those Who Completed the Education of Persons Conducting Clinical Trial Workers (의약품 임상시험 종사자 교육 이수자의 지식 수준, 태도, 교육 선택 요인 분석)

  • Lee, Yoon Jin;Jang, Hye Yun;Lee, Yu-Mi
    • The Journal of KAIRB
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    • v.3 no.2
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    • pp.19-27
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    • 2021
  • Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

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