NCT01888289已完成1 期
An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 40 mg of Roche Laboratories Inc., 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
- 35
- 试验地点
- 1
- 主要终点
- Area under curve (AUC)
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fasting conditions
详细描述
An open label, randomized, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males between 18 and 45 years of age inclusive.
- •Informed of the nature of the study and given written informed consent.
- •Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).
- •Exclusion Criteria
- •Hypersensitivity to isotretinoin or related compounds.
- •Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
- •Recent history of mental illness, drug addiction, drug abuse or alcoholism.
- •Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- •Received an investigational drug within the 4 weeks prior to study dosing.
- •Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
- •Regular tobacco use in the 3 months prior to study dosing.
排除标准
- 未提供
研究组 & 干预措施
Isotretinoin capsules, 40 mg
Experimental
Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd
干预措施: Isotretinoin (Drug)
ACCUTANE
Active Comparator
ACCUTANE 40 mg of Roche Laboratories Inc
干预措施: Isotretinoin (Drug)
结局指标
主要结局
Area under curve (AUC)
时间窗: Pre-dose (0) and 0.5, 1,2,3,4,5,6,8,10,16,24,36,48,72 and 96hrs
次要结局
未报告次要终点
研究者
研究点 (1)
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