An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)
研究概览
简要总结
This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 18 to 28 kg/m2;
- •total body weight within the range of 50 to 100 kg
排除标准
- •History of regular alcohol consumption exceeding 14 drinks/week
- •Use of tobacco- or nicotine-containing products in excess of the equivalent of 10 cigarettes per day
研究组 & 干预措施
Cohort 1
24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water.
干预措施: Amlodipine (Drug)
Cohort 2
24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without water, and treatment D) one 5 mg amlodipine 2nd OD tablet (reference) without water
干预措施: Amlodipine (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)
时间窗: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
Area under the concentration-time curve from zero time until the last sampling time
Maximum Observed Plasma Concentration (Cmax)
时间窗: prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose
次要结局
- Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)(prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose)
- Apparent Terminal Elimination Phase Rate Constant (Kel)(prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose)
- Apparent Terminal Elimination Half-Life (T-half)(prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose)
- Mean Residence Time (MRT)(prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose)