Clinical Bioequivalence Study on Two Metoprolol Tablet 100mg Formulations
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- Peak plasma concentration (Cmax) of metoprolol
研究概览
简要总结
The purpose of the study is to compare the bioavailability of a generic product of metoprolol with that of a reference product when administered to healthy volunteers under fasting conditions. The test product is BF-Metoprolol Tablets 100mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited and the reference product is Betaloc Tablet 100mg. The plasma kinetic data of metoprolol 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 cross over with a washout period of one to two weeks. Subject will be randomly assigned to two groups corresponding to two dosing sequences. Each subject will undergo two study (treatment) sessions, during which a single oral dose of 100mg metoprolol from either test or reference formulations will be administered. The estimated duration of subject's participation will be about 29-36 days (i.e. 3 weeks for screening and medication restraint, 1 day each for study (treatment) sessions I and II, 1 - 2 weeks as washout period. Venous blood samples will be collected at pre-dose (0h), and up to 24h post dose. The plasma concentrations of metoprolol 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 calculated 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
- 主要目的
- Other
- 盲法
- None
盲法说明
Open Label
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
- •Male and non-pregnant female, 18 to 55 years of age
- •Body Mass Index between 18 to 30 kg/m2
- •Accessible vein for blood sampling
- •High probability for compliance and completion of the study
- •Female subjects must agree to practice abstinence or take effective contraceptive methods to prevent pregnancy from the start of the screening and until two weeks of last dose administration
排除标准
- •Clinically significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- •Clinically significant abnormality in physical examination, vital sign, laboratory test results, ECG evaluation, urine test, blood chemistry or haematological test
- •Regular consumption of tobacco used in any forms
- •Regular consumer of alcohol (more than one drink per day)
- •Blood donation within 4 weeks prior to the start of the study
- •Use of metoprolol within 4 weeks before the study
- •Use of antihypertensive medications or other beta blockers within 4 weeks before the study
- •Volunteer in any other clinical drug study within 2 months prior to this study
- •Hypersensitivity to metoprolol 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-Metoprolol Tablet 100mg
During the study session, healthy subjects will be administered a single dose of BF-Metoprolol Tablet 100mg after an overnight fast of approximately 10 hours
干预措施: BF-Metoprolol Tablet 100mg (Drug)
Betaloc Tablet 100mg
During the study session, healthy subjects will be administered a single dose of Betaloc Tablet 100mg after an overnight fast of approximately 10 hours
干预措施: Betaloc Tablet 100mg (Drug)
结局指标
主要结局
Peak plasma concentration (Cmax) of metoprolol
时间窗: 24 hours
Area under the plasma concentration versus time curve (AUC) of metoprolol
时间窗: 24 hours
次要结局
- Time to maximum concentration (Tmax) of metoprolol(24 hours)
- Elimination half-life (t1/2) of metoprolol(24 hours)