NCT01170169已完成1 期
A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co.Inc., USA Under Fasting Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Bioequivalence based on Cmax and AUC parameters
研究概览
简要总结
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fasting condition.
详细描述
This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr.Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules (manufactured by Merck & Co., Inc., USA) in 44 healthy, adult, human subjects under fasting conditions.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who provided written informed consent.
- •Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
- •Body mass index of ≥ 18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- •Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
- •Subjects with normal ECG, chest X-ray (PA view) and vital signs.
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Test product, dose, mode of administration and batch number
排除标准
- 未提供
研究组 & 干预措施
Omeprazole
Experimental
Omeprazole Delayed Release Capsules of Dr. Reddy's laboratories limited
干预措施: Omeprazole (Drug)
Prilosec
Active Comparator
Prilosec® 40 mg of Merck & Co.Inc.
干预措施: Prilosec (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC parameters
时间窗: 5 months
次要结局
未报告次要终点
研究者
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