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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Warner Chilcott LLC Sarafem Tablets; Drug: Torrent's Fluoxetine Tablets

• Registration Number: NCT02965261
• Lead Sponsor: Torrent Pharmaceuticals Limited

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2016-11
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-14
• Last Update Submitted: 2016-11-14
• Study First Posted: 2016-11-16
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference	Warner Chilcott LLC Sarafem Tablets	Warner Chilcott LLC's Sarafem® Tablet 20 mg
Test	Torrent's Fluoxetine Tablets	Torrent's Fluoxetine Tablets 20 mg

Primary Outcome Measures

Name	Time	Method
Cmax	pre-dose to 72 hours post-dose
AUC	pre-dose to 72 hours post-dose