To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted Conditions

This study has been completed.

First Received: June 2, 2009 Last Updated: June 3, 2009 History of Changes

Sponsored by:	Sandoz Inc.
Information provided by:	Sandoz Inc.
ClinicalTrials.gov Identifier:	NCT00913783

Purpose

To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fasted conditions.

Condition	Intervention	Phase
Depression	Drug: Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals) Drug: Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	Comparative, Randomized, 2-Way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fasted Conditions

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Clomipramine hydrochloride Clomipramine

U.S. FDA Resources

Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:

Bioequivalence based on AUC and Cmax [ Time Frame: 34 days ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	November 1992
Study Completion Date:	December 1992
Primary Completion Date:	December 1992 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)	Drug: Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)
2: Active Comparator Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)	Drug: Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913783

Sponsors and Collaborators

Sandoz Inc.

Investigators

Principal Investigator:

Richard Lalonde, Pharm.D.

Phoenix International Life Science Inc.

More Information

No publications provided

Responsible Party:	Sandoz Inc. ( Eric Mittleberg, Ph.D, VP of Product Development )
Study ID Numbers:	920256
Study First Received:	June 2, 2009
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00913783 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sandoz Inc.:

Antidepressant

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Clomipramine
Psychotropic Drugs
Depressive Disorder

Serotonin Uptake Inhibitors
Serotonin
Antidepressive Agents
Antidepressive Agents, Tricyclic
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Clomipramine
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Behavioral Symptoms
Antidepressive Agents, Tricyclic
Serotonin Agents
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 10, 2009