Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Geometric Mean Ratio of AUCt
研究概览
简要总结
The study was conducted to investigate whether 20 mg omeprazole capsules manufactured by PT. Dankos Farma for PT. Hexpharm Jaya is bioequivalent to its reference product, 20 mg Losec® capsules manufactured by AstraZeneca AB, Sweden, imported by PT. AstraZeneca Indonesia.
详细描述
Thirty six healthy subjects were given a single dose of 20 mg omeprazole capsules or 20 mg Losec® capsules with 240 mL of water. Then the blood samples for omeprazole were drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 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
Omeprazole 20 mg capsules
Subjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water
干预措施: Omeprazole 20 mg Capsules (Drug)
Losec® 20 mg capsules
Subjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water
干预措施: Omeprazole 20 mg Capsules (Drug)
结局指标
主要结局
Geometric Mean Ratio of AUCt
时间窗: before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration
The ratio between area under curve from 0 to 10 hours of test drug and reference drug
Geometric Mean Ratio of Cmax
时间窗: before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration
The ratio between maximum concentration of test drug and reference drug after drug administration
次要结局
- Pharmacokinetics Parameter of Cmax(before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration)
- Pharmacokinetics Parameter of AUCt(before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration)