NCT01166087已完成1 期
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's and Prozac®Weekly 90 mg Delayed Release Capsules of Eli Lilly and Company, USA in Healthy Adult Human Subjects Under Fed 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
- 54
- 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 purpose of this study is to asses the bioequivalence study of Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg and Prozac ® weekly under fed conditions.
详细描述
A randomized, open label, two treatment, two period, two sequence, single dose, crossover bioequivalence study of Fluoxetine Hydrochloride Delayed-Release capsules 90 mg of Dr. Reddy's laboratories limited, Generics, India and Prozac®weekly 90 mg delayed release capsules of Eli Lilly and company, USA in healthy adult human subjects under fed 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of Life Insurance Corporation of India (11 Underweight and Overweight Min. & Max. Chart).
- •Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
- •Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
- •Informed consent given in written form according to section 11.3 of the protocol.
- •Female Subjects
- •of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies,diaphragm, intrauterine device, or abstinence.
- •postmenopausal for at least I year.
- •surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
排除标准
- •Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •Alcohol dependence, Alcohol abuse, i.e., regular use of more than 2 units of alcohol or 10 units per week or a history of alcoholism (one unit of alcohol equals 1/2 1 of beer 200 ml wine or 50 ml (of spirits) within last 6 months or recovered alcoholics , or drug abuse within past 1 year.
- •Moderate to heavy smoking (> 10 cigarettes/day) or consumption of tobacco products.
- •History of difficulty in swallowing capsules.
- •Clinically significant illness within 4 weeks before the start of the study.
- •Asthma, urticaria or other allergic type reactions after taking any medication.
- •Positive urine drug screening, Human Immunodeficiency Virus, Hepatitis B & C tests.
- •Any history of hypersensitivity to fluoxetine.
研究组 & 干预措施
Fluoxetine Hydrochloride
Experimental
Fluoxetine Hydrochloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories Limited
干预措施: Fluoxetine Hydrochloride (Drug)
Prozac ® weekly
Active Comparator
Prozac ® weekly 90 mg delayed release capsules of Eli Lilly and company
干预措施: Fluoxetine Hydrochloride (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC parameters
时间窗: 8 months
次要结局
未报告次要终点
研究者
研究点 (1)
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