• Title/Summary/Keyword: crossover design

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Negative Health Behavior, Mental Health and Self-Esteem Differences in Tattooed and Nontattooed University Students' (대학생 타투 소유 유무에 따른 부정적 건강행동, 정신건강 및 자아존중감의 차이)

  • Kim, Gyu-Rang;Myung, Kwang-Joo
    • Journal of the Korean Applied Science and Technology
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    • v.37 no.5
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    • pp.1257-1267
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    • 2020
  • This study was conducted to analyze the differences in negative health behavior, mental health, and self-esteem between tattooed and non-tattooed college students. The subjects of this study were 214 four-year college students located in Seoul and Gyeonggi-do. For data analysis, descriptive statistics, factor analysis, Cronbach's α, crossover analysis, and t-test were conducted using the 25.0 version of the SPSS statistical package. As a result of the study, there was no significant difference in negative health behavior, mental health, and self-esteem between the two groups according to the presence of tattoos. Therefore, it can be said that it has a meaning as a positive aspect of research contrary to previous studies that report negative properties of tattoo. This study is expected to be used as basic data in establishing tattoo culture suitable for the times by reflecting and activating tattoos as a cultural phenomenon in the future.

Milk Protein Production and Plasma 3-Methylhistidine Concentration in Lactating Holstein Cows Exposed to High Ambient Temperatures

  • Kamiya, Mitsuru;Kamiya, Yuko;Tanaka, Masahito;Shioya, Shigeru
    • Asian-Australasian Journal of Animal Sciences
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    • v.19 no.8
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    • pp.1159-1163
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    • 2006
  • This experiment was performed to examine the influences of high ambient temperature on milk production, nutrient digestibility, energy and protein sufficiency ratio, and plasma metabolites concentration in lactating cows. In a $2{\times}2$ crossover design, four multiparous lactating Holstein cows were maintained in a chamber under treatment of constant moderate ($18^{\circ}C$) ambient temperature (MT) or high ($28^{\circ}C$) ambient temperatures (HT). The DMI and milk protein yield were significantly lower in HT (p<0.05). The milk yield, milk lactose yield, and milk SNF yield tended to be lower in HT (p<0.10). No statistical differences for 4% fat-corrected milk and milk fat yield were observed. Rectal temperatures were significantly higher in HT than MT (p<0.05). The apparent DM, OM, ether extract, CF, and ash digestibility did not differ between treatments. On the other hand, the apparent CP digestibility was increased significantly (p<0.05) and nitrogen free extract tended to increase (p<0.10) in HT. The sufficiency ratio of ME and DCP intake for each requirement tended to be lower in HT than in MT (p<0.10). Concentrations of total protein (TP), albumin, and urea nitrogen in plasma did not differ between treatments. Plasma 3-methylhistidine (3MH) concentration as a marker of myofibrillar protein degradation tended to be higher in HT (p<0.15). In conclusion, high ambient temperature was associated with a lower energy and protein sufficiency ratio, and decreased milk protein production, even though the body protein mobilization tended to be higher.

Bioequivalence Assessment of Roxithromycin Tablets in Healthy Korean Volunteers

  • Kwon Oh-Seung;Kim Hye-Jung;Pyo Hee-Soo;Chung Youn-Bok
    • Biomolecules & Therapeutics
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    • v.14 no.1
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    • pp.50-55
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    • 2006
  • The objective of the study was to evaluate the bioequivalency between the $Rozid^{TM}$ Tablet (Ilhwa Pharm. Co., Ltd.) as a test formulation and the $Rulid^{TM}$ Tablet (Handok Pharm. Co., Ltd) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with fluorescence detector. $AUC_t,\;C_{max}\;and\;T_{max}$ were obtained from the time-plasma concentration curves, and log-transformed $AUC_t\;and\;C_{max}$ and log-untransformed $T_{max}$ values for two formulations were compared by statistical tests and analysis of variation. $AUC_t$ was determined to be $63.30{\pm}25.57{\mu}g.hr/ml$ for the test formulation and $64.02{\pm}29.27mg.hr/ml$ for the reference formulation. The mean values of $C_{max}$ for the test and reference formulations were $5.07{\pm}2.14\;and\;5.53{\pm}2.60{\mu}g/ml$, respectively. The $AUC_t,\;and\;C_{max}$ ratios of the test $Rozid^{TM}$ Tablet to the reference $Rulid^{TM}$ Tablet were -1.12% and -8.32%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for log-transformed $AUC_t,\;and\;C_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for $AUC_t,\;and\;C_{max}$ were located in ranges from log 0.80 and log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The RozidTM Tablet as the test formulation was considered to be bioequivalent to the RulidTM Tablet used as its reference formulation, based on $AUC_t,\;and\;C_{max}$ values.

Bioequivalence of Lisihexal® tablet to Zestril® tablet(Lisinopril 10 mg) (제스트릴®정(리시노프릴, 10 mg)에 대한 리시헥살®정의 생물학적동등성)

  • Oh, Soo-Yeon;Aryal Dipendra Kumar;Cho, Jong-Tae;Kim, Hyung-Gun;Kim, Yoon-Gyoon
    • Journal of Pharmaceutical Investigation
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    • v.36 no.4
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    • pp.277-282
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    • 2006
  • Lisinopril is one of the angiotensin-converting enzyme inhibitors, which have been used for treatment of hypertension and heart failure. The aim of this study was to evaluate the bioequivalence of two lisinopril tablet, $Lisihexal^{\circledR}$ and $Zestril^{\circledR}$ as a test and reference, respectively. The study was came out on 28 healthy male Korean volunteers in $2{\times}2$ crossover design. An analytical method with LC-MS-MS was developed for the quantification of lisinopril and enalapril(IS) using SPE method. The condition was selective, sensitive and precise in human plasma, that was enough for the pharmacokinetic study of lisinopril. The pharmacokinetic parameters such as $AUC_t,\;AUC_{inf},\;C_{max},\;T_{max}\;and\;t_{1/2}$ were calculated and ANOVA test was used for the statistical analysis of the parameters using log transformed $AUC_t,\;AUC_{inf}\;and\;C_{max}$. $t_{1/2}$ of test and reference drugs were calculated $11.4{\pm}5.1\;and\;16.1{\pm}9.9\;hr$, respectively. The 90% confidence intervals of $AUC_t,\;AUC_{inf}\;and\;C_{max}$ were log 0.9245$\sim$log 1.0603, log 0.9270$\sim$log 1.0601 and log 0.9548$\sim$log 1.1009, within the acceptable range of log 0.8 to log 1.25 by KFDA bioequivalence criteria. Two medications of lisinopril were evaluated bioequivalent and thus may be prescribed interchangeably.

Bioequivalence and Pharmacokinetics of Carvedilol (25mg) Tablets in Volunteers (카베딜롤(25mg)정제의 생물학적 동등성 및 약물동태연구)

  • 우수경;김호순;강종성;권광일
    • YAKHAK HOEJI
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    • v.45 no.6
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    • pp.650-655
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    • 2001
  • Carvedilol is a nonselective $\beta$-blocking agent with vasodilating properties that are attributed mainly to its blocking activity at $\alpha$$^{1}$-receptors. Carvedilol is used in the treatment of mild to moderate hypertention and angina pectoris and is often used in combination with other drugs. This study was carried out to evaluate the bioequivalence and pharmacokinetics of two carvedilol 25mg tablet formulations according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty healthy volunteers are enrolled and received a single dose (25mg as carvedilol) of each drug in the fasting state, in a randomized 2-way crossover design. After oral administration, blond samples were collected for a period of 30 hours. Plasma concentrations of carvedilol were determined by a rapid and sensitive HPLC method with spectrofluorometric detection. The major pharmacokinetic parameters such as AU $C_{0-}$30hr/, AU $C_{inf}$ , $C_{max}$, $T_{max}$, $t_{1}$2 / Cl/F and V $_{\beta}$//F were calculated. ANOVA test and t-test were utilized for the statistical analysis of each parameter. The results showed that the differences in AU $C_{0-}$30hr/, $C_{max}$ and $T_{max}$ between two were ~5.66, 1.74 and 0.00%, respectively. Minimum detectable differences ($\Delta$) at $\alpha$=0.05 were less than$\pm$ 20% except $T_{max}$ (8.44, 18.36, and 33.86%, respectively). The 90% confidence intervals of all parameters were within $\pm$20% (-10.60~ -0.72, -9.00~12.49 and -19.81~19.81%, respectively). Therefore, it is concluded that the two formulations are bioequivalent for both the extent and the rate of absorption after single dose administration.ation.ion.ion.ation.ion.n.

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Establishment of Injection Protocol of Test Bolus for Precise Scan Timing in Canine Abdominal Multi-Phase Computed Tomography

  • Choi, Sooyoung;Lee, In;Choi, Hojung;Lee, Kija;Park, Inchul;Lee, Youngwon
    • Journal of Veterinary Clinics
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    • v.35 no.3
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    • pp.93-96
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    • 2018
  • This study aimed to establish an injection protocol to determine the precise CT scan timing in canine abdominal multi-phase CT using the test bolus method. Three dynamic scans with different contrast injection parameters were performed using a crossover design in eight normal beagle dogs. A contrast material was administered at a fixed dose of 200 mg iodine/kg as a test bolus for dynamic scans 1 and 2, and 600 mg iodine/kg as a main bolus for dynamic scan 3. The contrast materials were administered with 1 ml/s in dynamic scan 1, and 3 ml/s in dynamic scan 2 and 3. The mean arrival time to the appearance of aortic enhancement in dynamic scan 3 was similar to that in dynamic scan 2, and different significantly to that in dynamic scan 1. The mean arrival time to the peak aortic and pancreatic parenchymal enhancement in dynamic scan 3 was similar to that in dynamic scan 1, and different significantly to that in dynamic scan 2. In multi-phase CT scan, a test bolus should be injected with the same injection duration of a main bolus, to obtain the precise arrival times to peak of arterial or pancreatic parenchymal enhancement.

Pharmacokinetics of Two Cyclosporine Formulations Using FPIA and HPLC Assay in Volunterrs

  • Kwon, Kwang-Il;Kim, Moo-Heon;Park, Jong-Woo;Lee, Chang-Hyun
    • Archives of Pharmacal Research
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    • v.18 no.6
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    • pp.385-390
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    • 1995
  • The analytical methods for the analysis of cyclosporine (CsA), a fluorescence polarization immunoassay (FPIA) and HPLC method, were compared in a pharmacokinetic study of two CsA soft capsule formultaions ($Sandimmun^{\circledR}$; Sandoz, $Implanta^{\circledR}$; Hanmi). Sixteen healthy volunteers completed the study and each subjected single doses ($4{\tiems}100$ mg) of the test and the reference formulations in a two-way crossover design with a one-week drug-free interval between doses. Following each administration, whole blood concentrations of CsA were monitored over a period of 24 hour by both FPIA and HPLC methods. Blood concentrations nad pharmacokinetic parameters determined by either analytical method showed large intersubject variation, with the FPIA data showing relatively higher magnitude of intersubjecte variation than the HPLC data. The blood concentrations determined by FPIA were 1.1-1.3 times higher than those determined by HPLC. There were strong and significant correlations between the two methods (r>0.83 : p<0.0001). Intersubuject variation for the $AUC_{inf}{\;}and{\;}AUC_{24hr}$ of the test formulation was slightly reduced without statistical significance (paried -t test : p>0.05 $t_{max}$ was earlier nad $C_{max}$ was slightly lower for the test formulation, $AUC_{24h}, {\;}C_{max}, {\;}T_{max}$ and MRT determined separately from the data obtained by the two methods for the two formulations were examined by analyses of variance (ANOVA) for the bioequivalency evaluation. Results of ANOVA and confidence limits of terst/reference ratios of $AUC_{24th}$, $C_{max}$, $t_{max}$ and MRT, and statistical tests indicated the bioequivalence of the two formulations (i.e., test/reference ratio was within $100{\times}20%$) except for $C_{max}$ and $t_{max}$. The mean of tmax also showed 11.1% and 9.3% differences but the detection limit were 29.2% and 29.6% as determined by FPIA and HPLC resepctively. This experiments suggest that the data yielded for the two formulations demonstrated that they were bioequivalent.

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Comparative Bioavailability and Metabolism of Two Capsule Formulations of Fluoxetine in Human Volunteers (플루옥세틴 캅셀제의 지원자에 대한 생체이용율 및 대사율 비교)

  • Kang, Won-Ku;Park, Yong-Soon;Cho, Gyu-Haeng;Choi, Jun-Sik;Kwon, Kwang-Il
    • YAKHAK HOEJI
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    • v.42 no.5
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    • pp.513-518
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    • 1998
  • Fluoxetine is a nontricyclic antidepressant which blocks serotonin reuptake selectively. Its N-demethyl metabolite, norfluoxetine is also selective inhibitor of serotonin uptake . This study was carried out to compare the bioavailability of Myung-in fluoxetine (20mg/cap.) with that of Prozac$^{\circde{R}}$. The bioavailability was conducted on 24 healthy volunteers who received a single dose (80mg) of each drug in the fasting state, in a randomized balanced 2-way crossover design. After closing, serial blood samples were collected for a period of 48 hours, Plasma was analyzed for fluoxetine and norfluoxetine by a sensitive and validated HPLC assay. The major pharmacokinetic parameters ($AUC_{0-48\;hr}$, Cmax, Tmax , $AUC_{inf.}$, MRT. $T_{1/2}$, Vd and Cl) were, calculated from the plasma fluoxetine concentration-time data of each volunteer. The microcomputer program, 'WinNonlin' was used for compartmental analysis. A two-compartment model with first-order input, first-order output and no lag time was chosen as the most appropriate pharmacokinetic model. The data were best described by using a weighting factor of $1/y^2$. Though the plasma fluoxetine concentrations of Myung-in fluoxetine were higher than those of Prozac$^{\circde{R}}$ at all observed time from 7.9% to 16.9% (P<0.05 at 6.7 and 10 hr), the bioavailability of Myung-in fluoxetine appeared to be bioequivalent with that of Prozac$^{\circde{R}}$. There were no statistical significant differences between the two drugs in all pharmacokinetic parameters including $AUC_{0-48\;hr}$ of norfluoxetine.

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The Effects of Sciatic Nerve Mobilization on Hamstring Flexibility, Lower Limb Strength and Gait Performance in Patients With Chronic Stroke

  • Shin, Yun-hyeok;Chon, Seung-chul
    • Physical Therapy Korea
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    • v.22 no.4
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    • pp.8-16
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    • 2015
  • The purpose of this study was to evaluate the effects of mobilization of the sciatic nerve on hamstring flexibility, lower limb strength, and gait performance in patients with chronic stroke. This study was a randomized clinical trial with a crossover design. Sixteen subjects were recruited for this study. The subjects were randomly divided into two intervention groups and underwent either of the following two interventions: sciatic nerve mobilization or static stretching of the hamstring. We assessed hamstring flexibility, lower limb strength, and gait performance using a digital inclinometer, a hand-held dynamometer, and the 10-meter walk test, respectively. Subjects had a 24-hour rest period between each session in order to minimize carryover effects. Measurements for each test were assessed prior to and immediately after the intervention sessions. Using a two-way analysis of variance test with repeated measures, data from the two trials were analyzed by comparing the differences between both techniques. The level of statistical significance was set at .05. Sciatic nerve mobilization resulted in significantly better knee extensor strength (p=.023, from $15.32{\pm}5.98$ to $18.16{\pm}6.95kg$) and knee flexor strength (p=.011, from $7.80{\pm}4.80$ to $8.15{\pm}4.24kg$) in the experimental group than in the control group. However, no significant effects of static stretching of the hamstring were observed on hamstring flexibility from the ankle plantar flexion (p=.966) and ankle neutral positions (p=.210) and on gait performance (p=.396). This study indicated that the sciatic nerve mobilization technique may be more effective in muscle activation of the knee extensor muscle and knee flexor muscle than hamstring static stretching technique in patients with chronic stroke.

Bioequivalence of Cisaplus Tablets to Prepulsid Tablets (Cisapride 5 mg) (프레팔시드 정 (시사프리드 5 mg)에 대한 시사프러스 정의 생물학적 동등성)

  • Yoo, Sun Dong;Jun, Hun;Shin, Beom Soo;Park, Joon Woo;Kim, Hak Hyung
    • Korean Journal of Clinical Pharmacy
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    • v.10 no.1
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    • pp.25-29
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    • 2000
  • Bioequivalence of cisapride-containing $Cisaplus^{(R)}$ tablets (Daewoong Co.) to reference $Prepulsid^{(R)}$ tablets (Janssen Co.) was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy volunteers were divided randomly into two groups and administered orally at a cisapride dose of 10 mg in a $2\times2$ crossover design. There was a 1-week washout period between the treatments. Blood samples were taken at predetermined time intervals for 48 hr and the plasma cisapride concentrations were determined by an HPLC with UV detector. The area under the plasma drug concentration-time curve (AUC) was caltulated from time zero to the last sampling time by a linear trapezoidal method. The maximum observed plasma drug concentration ($C_{max}$) and the time to $C_{max}\;(T_{max})$ were estimated directly from the drug concentration-time data. Analysis of variance (ANOVA) showed that the apparent differences for AUC, $C_{max}\;and\;T_{max}$ were $-7.52\%,\;-8.91\%\;and\;-15.55\%$, respectively. The minimum detectable differences for AUC, $C_{max}\;and\;T_{max}$ between formulations were $14.52\%,\;11.57\%\;and\;28.00\%$ respectively, at $\alpha=0.05\;and\;1-\beta=0.8\;levels.\;The\;90\%$ confidence intervals for AUC, $C_{max}\;and\;T_{max}\;were\;-16.00\sim0.97\%,\;-15.67\sim-2.15\%\;and\;-31.88\%\sim0.84\%$, respectively. These results satisfy the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of cisapride are bioequivalent.

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