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

NCT02965261 | Completed Phase 1

• 1 other identifier: PK-12-056
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Cmax

  pre-dose to 72 hours post-dose

• AUC

  pre-dose to 72 hours post-dose

Study Arms (2)

Test

EXPERIMENTAL

Torrent's Fluoxetine Tablets 20 mg

Drug: Torrent's Fluoxetine Tablets

Reference

ACTIVE COMPARATOR

Warner Chilcott LLC's Sarafem® Tablet 20 mg

Drug: Warner Chilcott LLC Sarafem Tablets

Interventions

Torrent's Fluoxetine Tablets DRUG

Test

Warner Chilcott LLC Sarafem Tablets DRUG

Reference

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 16, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share