Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 主要终点
- Peak plasma concentration (Cmax) of amlodipine
研究概览
简要总结
The purpose of the study is to compare the bioavailability of a generic product of amlodipine with that of a reference product when administered to healthy volunteers under fasting conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine 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 two to three weeks. During each session, the subjects will be administered a single oral dose of 10mg amlodipine (one BF-Amlodipine Tablet 10mg or one Norvasc Tablet 10mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0 h), and up to 96 h post dose. The plasma concentrations of amlodipine 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 Peak plasma concentration (Cmax), Time to maximum concentration (Tmax), Area under the plasma concentration versus time curve (AUC0-last, AUC0-inf) and Elimination half-life (T1/2). Analysis of Variance (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
- All
- 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
- •Electrocardiogram (ECG) recording within normal limits
- •Biochemical and haematological parameters within normal limits
- •Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until two weeks 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 and haematological test
- •Tobacco use in any forms
- •Regular consumer of alcohol
- •Blood donation within 4 weeks prior to the start of the study
- •Use of amlodipine within 4 weeks before the study
- •Use of antihypertensive medications within 4 weeks before the study
- •Volunteer in any other clinical drug study within 2 months prior to this study
- •Hypersensitivity to amlodipine or other drugs in its class
- •History of drug abuse in any form
- •Female subjects who are breastfeeding or pregnant
研究组 & 干预措施
BF-Amlodipine Tablet 10mg
During the study session, healthy subjects will be administered a single dose of BF-Amlodipine Tablet 10mg after an overnight fast of approximately 10 hours
干预措施: BF-Amlodipine Tablet 10mg (Drug)
Norvasc Tablet 10mg
During the study session, healthy subjects will be administered a single dose of Norvasc Tablet 10mg after an overnight fast of approximately 10 hours
干预措施: Norvasc Tablet 10mg (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of amlodipine
时间窗: 96 hours
Area under the plasma concentration versus time curve (AUC) of amlodipine
时间窗: 96 hours
次要结局
- Time to maximum concentration (Tmax) of amlodipine(96 hours)
- Elimination half-life (t1/2) of amlodipine)(96 hours)