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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02965274
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Torrent's Fluoxetine Tablets Drug: Warner Chilcott LLC's Sarafem Tablet Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Fluoxetine Tablets 20 mg [Torrent,India] Versus Sarafem 20 mg Tablet [ Warner Chilcott LLC, USA] in Healthy Subjects-Fed Condition.
Study Start Date : November 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: Test
Torrent's Fluoxetine Tablets 20 mg
Drug: Torrent's Fluoxetine Tablets
Active Comparator: Reference
Warner Chilcott LLC, USA
Drug: Warner Chilcott LLC's Sarafem Tablet

Primary Outcome Measures :
  1. Cmax [ Time Frame: pre-dose to 72 hours post-dose ]
  2. AUC [ Time Frame: pre-dose to 72 hours post-dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

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Responsible Party: Torrent Pharmaceuticals Limited Identifier: NCT02965274    
Other Study ID Numbers: PK-12-057
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors