Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg and Merck & Co., Propecia in Healthy Adult Males Under Fed Condition.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Bioequivalence based on Cmax and AUC parameters
研究概览
简要总结
The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®)
1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.
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 24 healthy adult male volunteers and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 3 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 finasteride or any other 5-a reductase inhibitor.
- •Subjects who have been on an abnormal diet (for whatever reason) during the 28 days 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 prior to the first dosing.
研究组 & 干预措施
Finasteride
Finasteride tablets 1 mg of Dr. Reddy's
干预措施: Finasteride (Drug)
Propecia
Propecia 1 mgTablets of Merck & Co.,
干预措施: Finasteride (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC parameters
时间窗: 3 months
次要结局
未报告次要终点