Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablet Under Fasting Conditions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Torrent's Fluoxetine Tablets
* Drug: Warner Chilcott LLC Sarafem Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Torrent's Fluoxetine Tablets 20 mg | Drug: Torrent's Fluoxetine Tablets<br> <br> |
| Active Comparator: Reference<br>Warner Chilcott LLC's Sarafem® Tablet 20 mg | Drug: Warner Chilcott LLC Sarafem Tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | pre-dose to 72 hours post-dose | 
| AUC |  | pre-dose to 72 hours post-dose |