• Title/Summary/Keyword: Cross-over trials

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Bioequivalence of Procezil Tablet 250 mg to $Cefzil^{(R)}$ Tablet 250 mg (Cefprozil 250 mg) (세프질$^{(R)}$ 정 250밀리그람 (세프프로질 250밀리그람)에 대한 프로세질 정 250밀리그람의 생물학적동등성)

  • Kim, Se-Mi;Kang, Min-Sun;Cho, Hea-Young;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.3
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    • pp.255-261
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    • 2010
  • Cefprozil is a broad-spectrum oral beta-lactam cephalosporin consisting of cis- and trans-isomeric mixture whose ratio is approximately 90:10. Cefprozil is used to treat certain infections caused by bacteria such as bronchitis and ear, skin, and throat infections. The purpose of the present study was to evaluate the bioequivalence of two cefprozil tablets, $Cefzil^{(R)}$ tablet 250 mg (BMS Pharmaceutical Korea., Ltd.) and Procezil tablet 250 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of cefprozil from the two cefprozil formulations were tested using KP VIII Apparatus I method with water dissolution media. Thirty five healthy male subjects, $24.00{\pm}1.53$ years in age and $69.77{\pm}9.99$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After four tablets containing 1000 mg as cefprozil were orally administered, blood samples were taken at predetermined time intervals and the concentrations of cefprozil in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in water tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ on the basis of total-cefprozil were calculated, and computer program (K-BE Test 2002) was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Cefzil^{(R)}$ tablets, were -0.81%, -3.00% and -6.83% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.9515~log 1.0454 and log 0.9613~log 1.0465 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procezil tablet was bioequivalent to $Cefzil^{(R)}$ tablet.

Bioequivalence of Bambucol Tablet 10 mg to $Bambec^{(R)}$ Tablet 10 mg (Bambuterol Hydrochloride 10 mg) (밤벡$^{(R)}$ 정 10밀리그람(염산밤부테롤 10밀리그람)에 대한 밤부콜 정 10밀리그람의 생물학적동등성)

  • Cho, Hea-Young;Choi, Ji-Hoon;Yoo, Hee-Doo;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.3
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    • pp.235-241
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    • 2010
  • Bambuterol hydrochloride, dimethylcarbamic acid 5-[2-(1,1-dimethylethyl)amino-1-hydroxyethyl]-1,3-phenylene ester hydrochloride, is the prodrug of active ${\beta}_2$-adrenergic metabolite terbutaline. The purpose of the present study was to evaluate the bioequivalence of two bambuterol hydrochloride tablets, $Bambec^{(R)}$ tablet 10 mg (Yuhan Co., Ltd.) and Bambucol tablet 10 mg (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). In vitro release of bambuterol from two bambuterol hydrochloride formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male Korean volunteers, $23.86{\pm}1.65$ years in age and $68.98{\pm}9.58$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 10 mg as bambuterol hydrochloride were orally administered, blood samples were taken at predetermined time intervals, and the concentrations of bambuterol in serum were determined using column switching HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test with K-BE Test 2002 was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Bambec^{(R)}$, were -8.10%, -3.82% and 12.65% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (i.e., log 0.8093~log 1.0302 and log 0.8564~log 1.1280 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Bambucol tablet 10 mg was bioequivalent to $Bambec^{(R)}$ tablet 10 mg.

A New Mini Kiwifruit Cultivar, "Green King" (다래 신품종 "그린킹")

  • Kim, Chun-Hwan;Kim, Seong-Cheol;Song, Eun-Young;Ro, Na Young;Kim, Misun;Moon, Doo-Young;Kang, Kyung Hee;Jang, Ki-Chang
    • Korean Journal of Breeding Science
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    • v.40 no.4
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    • pp.461-465
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    • 2008
  • "Green King" is a new mini kiwifruit variety developed at the National Institute of Subtropical Agriculture (NISA), RDA in 2005, which was an edible fruit without peeling. This variety was selected from seeds obtained from the cross breeding between Actinidia chinensis cv. "Apple Sensation" and A. arguta in 1998. Seedling and line selections were conducted from 1999 to 2002, and characteristic trials were carried out from 2003 to 2004. The branch of "Green King" sprouts strongly and the color of leaf is slightly dark green. The shape of fruit is cylindric and the color of peel is green or yellowish green without hair. The average weight of fruit is 15.9 g. The core is small and soft, the pericarp is light green. Soluble solids concentration is $15.4^{\circ}Brix$. The fruit is sweet with slightly acid taste, containing total acid 1.3%, and the yield is higher over twice than that of A. arguta. The content of vitamin C is higher than that of A. arguta. The harvesting time is from middle October. This variety can be planted in the central and southern region of Korea.

A New Short Growth-Duration Rice Cultivar, "Keumo 3" (소득작물 전후작용 단기성 벼 품종 "금오3호")

  • Kang, Jong-Rae;Lee, Jong-Hee;Kwack, Do-Yeon;Lee, Jeom-Sik;Park, No-Bong;Ha, Woon-Gu;Park, Dong-Soo;Yeo, Un-Sang;Lim, Sang-Jong;Oh, Byeong-Geun
    • Korean Journal of Breeding Science
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    • v.41 no.3
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    • pp.292-298
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    • 2009
  • A new rice cultivar "Keumo 3" was developed for adopting under double cropping system with after or before cash crop cultivation. It was selected from the cross-combination between YR17202 $F_2$/Shinkeumobyeo//YR15727-B-B-B-102. The parent, YR17202 $F_2$ individual plant, was used for tolerance to lodging, it derived from a cross between Nonganbyeo/Shinkeumobyeo. Nonganbyeo is well known to lodging tolerance cultivar, as well as biotic stress, because it was developed by crossing with Tongil type. And the YR15727-B-B-B-102 line used as another parent with short growth duration, likewise highly resistance to rice blast disease. The pedigree derived from the cross-combination YR17202 $F_2$/Shinkeumobyeo//YR15727-B-B-B-102 were generated to $F_7$, and a best line among them named as Milyang 201. After a series of yield trials, including local adaptability test conducted throughout the peninsular of Korea, Milyang 201 was registered with the name of "Keumo 3" in 2005. The cultivar belongs to a early maturing group and heads 4 days earlier than Keumobyeo, a standard cultivar. It has short culm, and less spikelet number per panicle than Keumobyeo. However, its milled rice yield grown under extremely late transplanting time, 10. July, over the 3 local sites for 2003-2005 years, averaged 4,48 MT/ha, which is 6% higher than the standard, Keumobyeo. "Keumo 3" has showed a durable resistance to leaf blast disease during fourteen blast nurseries screening covered from south to north in Korea for 2003-2007 years. And it was confirmed harbours pi-zt, a durable blast resistance gene. Moreover it was incompatible with 19 blast isolates under artificial inoculation, except one isolate, K1101. Additionally, "Keumo 3" exhibits resistance to $K_1$, $K_2$ and $K_3$ of bacterial blight pathogen, as well as strip virus disease resistance, and moderate resistance to dwarf virus disease. Consequently, the new rice cultivar "Keumo 3" would be well adopted where a bio stress makes a big problem annually.

A New Sweetpotato Variety for Table Use, 'Pungwonmi' (식용 고구마 신품종 '풍원미')

  • Lee, Hyeong-Un;Lee, Joon-Seol;Chung, Mi-Nam;Han, Seon-Kyeong;Kim, Jae-Myung;Yang, Jung-Wook;Ahn, Seung-Hyun;Nam, Sang-Sik;Song, Yeon-Sang;Moon, Jin-Young;Cho, Kyu-Hwan;Shin, Hyun-Man;Lim, Sang-Hyun;Choi, In-Hu
    • Korean Journal of Breeding Science
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    • v.49 no.4
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    • pp.420-427
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    • 2017
  • 'Pungwonmi', a new sweetpotato variety, was developed for table use by Bioenergy Crop Research Institute, National Institute of Crop Science (NICS), RDA in 2014. This variety was derived from the cross between 'Benisatsuma' and 'Luby3074' in 2006. The seedling and line selections were performed from 2007 to 2009, and preliminary and advanced yield trials were carried out from 2010 to 2011. The regional yield trials were conducted at five locations from 2012 to 2014, and it was named as 'Pungwonmi'. This variety has cordate leaf shape, and its leaves, stems, nodes, and petioles are green. Storage root of 'Pungwonmi' has an elliptical shape, red skin, and light orange flesh. 'Pungwonmi' was moderately resistant to fusarium wilt, and resistant to root-knot nematode. Dry matter content was 31.2%, and texture of steamed storage root was intermediate. Total sugar content of raw and steamed storage roots of 'Pungwonmi' was higher than that of 'Yulmi'. ${\beta}$-carotene content of 'Pungwonmi' was 9.1 mg/100g DW. Yield of marketable storage root over 50 g of 'Pungwonmi' was 24.3 MT/ha under the early season culture, which was 46% higher than that of 'Yulmi'. The number of marketable storage roots per plant was 2.8 and the average weight of marketable storage root was 156 g under the optimal and late season culture. Marketable storage root yield of 'Pungwonmi' was 24.1 MT/ha under the optimum and late season culture, which was 26% higher than that of 'Yulmi'. (Registration No. 6428).

A DOUBLE BLIND CROSS-OVER COMPARISON OF ANTIDEPRESSANT AND ANTIANXIETY EFFECTS OF PAROXETINE AND PLACEBO IN CHILD-ADOLESCENT AND ADULT DEPRESSIVE NEUROSIS (소아 ${\cdot}$ 청소년 및 성인 우울신경증 환자에 대한 Paroxetine의 항우울 및 항불안 효과 검증 : 위약과의 이중맹 교차 비교실험)

  • Kim, S. Peter;Hong, Kyung-Sue
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.5 no.1
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    • pp.83-92
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    • 1994
  • Paroxetine is a potent and selective serotoin re-uptake inhibitor. It is well known as an effective and safe antidepressant and increasingly used for neurotic or non-psychotic depression with anxiety symptoms. The present study assessed antidepressant and antianxiety efficacy and tolerability of paroxetine against placebo in child-adolescent and adult depressive neurosis patients. 232 subjects aged 8-55 years and meeting DSM-III-R criteria for depressive neurosis or dysthymia were divided into 8 subgroups according to their sex and age(8-11 yeard old, 12-17 years old, 18-35 years old and 36-55 years old subgroup in each male and female group). In each subgroup, the randomly assigned half of the patients were treated with paroxetine(10-30mg/day) and the others with placebo for the first 2 weeks in double blind fashion. After 1 week of drug-washout period, paroxetine and placebo groups were crossed over. The depression and anxiety symptoms were assessed with Hamilton Depression Scale(HDS) and Hamilton Anxiety Scale(HAS) at baseline and every 1 week during the trial periods. The levels of reduction in HDS and HAS scores from baseline after 2-week trial were compared between paroxetine- and placebo- treated periods by paired t-test. In all the 8 subgroups, statistically significant differences between paroxetine and placebo were found on the antidepressant efficacy after 2-week treatment. The antidepressant efficacy of paroxetine compared to placebo was most prominent in child and adolescent female groups. On anxiety symptoms, paroxetine was also significantly more effective than placebo. The antianxiety efficacy of paroxetine compared to placebo was most prominent in male and female child groups and young adult female group aged 18-35 years. As for the adverse effects of paroxetine, 3 out of 232 subjects reported mild indigestion and abdominal pain. however, in all the 3 cases, the symptoms improved without reduction of dosage or discontinuation of the drug. In conclusion, paroxetine showed significantly higher antidepressant and antianxiety efficacy compared to placebo in child-adolescent and adult depressive neurosis patients after 2-week treatment. Further trials of paroxetine in depressive neurosis are warranted to elucidate the long-term antidepressant and antianxiety efficacy of paroxetine.

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