An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE Study of Fluoxetine Tablets 20 mg [Torrent,India] Versus Sarafem 20 mg Tablet [ Warner Chilcott LLC, USA] in Healthy Subjects-Fasted Condition.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Cmax
研究概览
简要总结
Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.
详细描述
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Fluoxetine Tablets containing Fluoxetine 20 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Sarafem® 20 mg Tablets containing Fluoxetine 20 mg (Reference , Warner Chilcott LLC, USA) in Healthy Human Volunteers Under Fasting Condition.
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
- •Sex: male
- •Age: 18-45 years (inclusive both)
- •Volunteer with BMI of 18.5-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- •Healthy and willing to participate in the study.
- •Volunteer willing to provide written informed consent.
- •Non-smokers or smoker who smokes less than 10 cigarettes per day.
排除标准
- •Inability to communicate or co-operate.
- •Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- •History of pre-existing bleeding disorder.
- •Clinically relevant abnormalities in the results of the laboratory screening evaluation.
- •Clinically significant abnormal ECG or Chest X-ray.
- •HIV, HCV, HBsAg positive volunteers.
- •History of significant blood loss due to any reason, including blood donation in the past 3 months.
- •Participation in any study within past 3 months,
- •History of alcohol or drug abuse.
- •History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study. Positive to Breath alcohol test.
- •Positive to breath alcohol test.
- •Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
- •Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mm Hg or more than 89 mm Hg.
- •Pulse rate less than 60/minute or more than 100/minute.
- •Oral temperature less than 95°F or more than 98.9°F.
- •Respiratory rate less than 10/minute or more than 20/minute.
- •History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- •Recent History of kidney or liver dysfunction.
- •Volunteers suffering from any psychiatric (acute or chronic) disorder.
- •Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
研究组 & 干预措施
Test
Torrent's Fluoxetine Tablets 20 mg
干预措施: Torrent's Fluoxetine Tablets (Drug)
Reference
Warner Chilcott LLC's Sarafem® Tablet 20 mg
干预措施: Warner Chilcott LLC Sarafem Tablets (Drug)
结局指标
主要结局
Cmax
时间窗: pre-dose to 72 hours post-dose
AUC
时间窗: pre-dose to 72 hours post-dose
次要结局
未报告次要终点