AN OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, CROSSOVER, SINGLE ORAL DOSE, BIOEQUIVALENCE STUDY OF METFORMIN 1000 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 1000 MG TABLETS MANUFACTURED BY MERCK SANTE S.A.S.2, RUE DU PRESSOIR VERT-45400 SEMOY-FRANCE AND BE REGISTERED IN VIETNAM IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Cmax, Tmax, AUC0-t, AUC0-∞, AUC%_Extrap, Kel and t1/2
研究概览
简要总结
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study to demonstrate the bioequivalence of Metformin 1000 mg tablets manufactured by Savipharm J.S.C, Vietnam and Glucophage® 1000 mg tablets of Merck Sante, France in healthy adult human male subjects under fasting condition
详细描述
Sample Size Estimation Assuming the formulation ratio (T/R) 95-105% and with the maximum observable intra subject variability for Metformin is 22% (based on literature), a sample size of 29 subjects would be sufficient to prove bioequivalence between the two formulations with power of at least 90%. Hence, total 32 subjects will be enrolled in the study considering withdrawal and dropouts.
Screening procedures: Demographic data, medical and medication histories, complete physical examination, height, weight and BMI as well as 12 lead ECG, chest X-ray [PA view], vital signs [blood pressure, pulse rate, respiratory rate and oral temperature], hematology, biochemistry, HIV 1 & 2, Hepatitis B and C, RPR test for Syphilis and urine analysis will be done at screening.
Urine drug screen, Liver chemistry test and breath alcohol test to be done prior to each check-in.
Breath alcohol test to be done prior to each ambulatory visit blood collection. Liver chemistry test to be done at the end of each period. Housing: The study subjects will be housed at least 11 h prior to drug administration until after the 24 h blood sampling in each study period. The housing will be followed by one ambulatory visits [36.0 hr post dose] for each period.
Washout: At least 7 days, but not exceeding 14 days between two dosing days. Treatment arms: Test: A single dose of Metformin 500 mg tablet manufactured by Savipharm J.S.C, Vietnam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Metformin GSK 1000mg
open label, crossover, two period, two treatment, two sequence, single dose of Metformin 1000mg
干预措施: Metformin GSK 1000mg (Other)
Glucophage 1000mg
open label, crossover, two period, two treatment, two sequence, single dose of Glucophage 1000mg to asset bioequivalence
干预措施: Metformin GSK 1000mg (Other)
结局指标
主要结局
Cmax, Tmax, AUC0-t, AUC0-∞, AUC%_Extrap, Kel and t1/2
时间窗: 7 days
Statistical analyses will be done using SAS® version 9.2 or higher. Analysis of variance \[ANOVA\] for log-transformed pharmacokinetic parameters \[Cmax, AUC0-t and AUC0-∞\] and two one-sided tests \[Schuirmann\] for bioequivalence will be performed. Power, ratio and 90% confidence interval for log-transformed pharmacokinetic parameters - Cmax, AUC0-t and AUC0-∞ will be calculated.The calculated 90% Confidence Interval for the test to reference ratio of Metformin should fall within the range of 80%-125% for log transformed Cmax, AUC0-t and AUC0-∞ for the conclusion of bioequivalence
次要结局
- Safety profile(14 days)