Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablets Under Fed Conditions

Phase 1

Completed

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

• Registration Number: NCT02965274
• 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 Fed 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
Test	Torrent's Fluoxetine Tablets	Torrent's Fluoxetine Tablets 20 mg
Reference	Warner Chilcott LLC's Sarafem Tablet	Warner Chilcott LLC, USA

Primary Outcome Measures

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