NCT00870480已完成1 期
Randomized, 2-Way Crossover Bioequivalence Study Finasteride 5 mg Tablet and Proscar Administrated as 1 x 5 mg Tablet in Healthy Subjects 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
- 发起方
- Actavis Inc.
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Rate and Extend of Absorption
研究概览
简要总结
The purpose of this study to compare the rate and extent of absorption of Actavis Group hf, Iceland, finasteride and Merck & Co. Inc., U.S.A. (Proscar), finasteride, administered as a 1 x 5 mg tablet, under fasting conditions.
详细描述
Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.
Official Title: Randomized, 2-Way Crossover, Bioequivalence Study of Finasteride 5 mg Tablet and Proscar Administered as 1 x 5 mg Tablet in Healthy Subjects Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, smoker or non-smoker, 18 years of age and older.
- •Capable of consent.
- •BMI ~19.0 and <30.0 kg/m2 Sexual abstinence for the duration of the study is recommended given the potential harm to a fetus from migration of this drug to the semen. Sexually-active males must refrain from heterosexual intercourse without the use of a condom for a period of one week from the initial dosing.
排除标准
- •Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- •Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- •Any clinically significant abnormality found during medical screening.
- •Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- •Abnormal laboratory tests judged clinically significant.
- •Positive testing for hepatitis B, hepatitis C, or HN at screening.
- •EeG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- •History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
- •Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [I Unit:= 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- •Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- •History of allergic reactions to heparin, finasteride, or other related drugs.
- •Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- •Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication .
- •Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- •.• Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- •Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (incl~ding natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- •Difficulty to swallow study medication.
- •Smoking more than 25 cigarettes per day.
- •Any food alIergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
- •A depot injection or an implant of any drug within 3 months prior to administration of study medication.
- •Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
- •50 mL to 300 mL of whole blood within 30 days,
- •301 mL to 500 mL of whole blood within 45 days, or
- •more than 500 mL of whole blood within 56 days prior to drug administration.
- •Consumption of food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
研究组 & 干预措施
A
Experimental
Finasteride 5 mg single dose tablet, single dose
干预措施: Finasteride 5 mg Tablet, single dose (Drug)
B
Active Comparator
Proscar® 5 mg Tablet, single dose
干预措施: Proscar® 5 mg Tablet, single dose (Drug)
结局指标
主要结局
Rate and Extend of Absorption
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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