Open-label, Randomized, 2-way Crossover Study to Compare the Bioavailability of Reddy Cheminor and Merck &Co, Pepcid Famotidine Tablets 40 mg Under Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC)
研究概览
简要总结
The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck &Co, pepcid 40 mg famotidine tablets under fasting conditions.
详细描述
Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 30 healthy adult male volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days.
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
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History or presence of significant:
- •cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
- •In addition, history or presence of:
- •alcoholism or drug abuse within the past year;
- •hypersensitivity or idiosyncratic reaction to famotidine or any other histamine H2-receptor antagonist; Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- •Subjects who, through completion of the study, would have donated in excess of:
- •500 mL of blood in 14 days, or
- •500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
- •1000 mL of blood in 90 days,
- •1250 mL of blood in 120 days,
- •1500 mL of blood in 180 days,
- •2000 mL of blood in 270 days,
- •2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days of study start.
研究组 & 干预措施
Famotidine
Famotidine tablets 40 mg of Dr. Reddy's
干预措施: Famotidine (Drug)
Pepcid
Pepcid 40 mg Tablets of Merck & Co.,
干预措施: Pepcid (Drug)
结局指标
主要结局
Area Under Curve (AUC)
时间窗: predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose.
次要结局
未报告次要终点