A Randomized, Single-dose, Two-treatment, Two-way, Crossover Bioequivalence Study of Finasteride 5 mg Tablets (Dr. Reddy's Laboratories Limited) With the Reference Formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.) Under Fed Conditions in Healthy Adult Male Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 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 evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fed conditions in healthy adult male subjects.
详细描述
This randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 5 mg finasteride tablets under fed conditions. The study was conducted with 26 (24 completed) healthy adults. The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males, 18-65 years of age (inclusive).
- •A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures.
- •Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- •Signed and dated informed consent form, which meets all criteria of current FDA regulations.
排除标准
- •History of allergy or sensitivity to finasteride, or similar drugs, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- •Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
- •Presence of gastrointestinal disease or history of malabsorption within the last year.
- •History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
- •Presence of a medical condition requiring regular treatment with prescription drugs.
- •Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing.
- •Receipt of any drug as part of a research study within 30 days prior to dosing.
- •Drug or alcohol addiction requiring treatment in the past 12 months.
- •Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
- •Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- •Positive test results for drugs of abuse at screening.
研究组 & 干预措施
Finasteride tablets 5 mg
Finasteride tablets 5 mg of Dr.Reddy's Laboratories Limited
干预措施: Finasteride (Drug)
Proscar 5 mg Tablets
Proscar 5 mg Tablets of Merck & Co. Inc
干预措施: Finasteride (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC parameters
时间窗: 2 months
次要结局
未报告次要终点