Clinical Bioequivalence Study on Two Gliclazide 80mg Tablet Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Peak plasma concentration (Cmax) of gliclazide
研究概览
简要总结
The purpose of the study is to compare the bioavailability of a generic product of gliclazide (Product Name: BF-Gliclazide Tablet 80mg, Manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited) with that of reference product (Product Name: Diamicron 80mg Tablet, Manufactured by Les Laboratoires Servier Industrie, France) when administered to healthy volunteers under fasting conditions. The plasma pharmacokinetic data of gliclazide obtained from two formulations will be used to access the interchangeability of the products.
详细描述
The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, healthy male subjects will be administered a single oral dose of 80 mg gliclazide (one BF-Gliclazide Tablet 80 mg or one Diamicron 80 mg Tablet) after an overnight fast of approximately 10 hours. 20% glucose will be given orally to each subject at 2 h after drug administration to minimize the risk of hypoglycaemia. Venous blood samples will be collected at pre-dose (0 h) and up to 72 hours post-dose. The plasma concentrations of gliclazide will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf and T1/2. ANOVA will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one-sided tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax, and to assess the bioequivalence of the two products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index between 18 to 27
- •Accessible vein for blood sampling
- •High probability for compliance and completion of the study
- •No significant abnormalities in general physical examination
- •ECG recording within normal limits
- •Biochemical and haematological parameters within normal limits
- •Subjects must agree to take effective contraceptive methods to prevent his partner from becoming pregnant during the time of first dose of study medication until one week of last dose administration
排除标准
- •History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- •Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry or haematological test
- •Tabacco use in any forms
- •Regular consumer of alcohol
- •Blood donation within 4 weeks prior to the start of the study
- •Use of gliclazide within 4 weeks before the study
- •Use of antidiabetic medications within 4 weeks before the study
- •Volunteer in any other clinical drug study within 2 months prior to this study
- •Hypersensitivity to gliclazide or other drugs in its class
- •History of drug abude in any form
研究组 & 干预措施
BF-Gliclazide Tablet 80mg
During the study session, healthy male subjects will be administered a single oral dose of BF-Gliclazide Tablet 80 mg after an overnight fast of approximately 10 hours.
干预措施: BF-Gliclazide Tablet 80mg (Drug)
Diamicron 80mg Tablet
During the study session, healthy male subjects will be administered a single oral dose of Diamicron 80 mg Tablet after an overnight fast of approximately 10 hours.
干预措施: Diamicron 80mg Tablet (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of gliclazide
时间窗: 72 hours
Area under the plasma concentration versus time curve (AUC) of gliclazide
时间窗: 72 hours
次要结局
- Time to maximum concentration (Tmax) of gliclazide(72 hours)
- Elimination half-life (t1/2) of gliclazide(72 hours)