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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913952
First Posted: June 4, 2009
Last Update Posted: March 28, 2017
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.
Information provided by:
Sandoz
  Purpose
To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fed and fasted conditions.

Condition Intervention Phase
Depression Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions Drug: Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative, Randomized, 3-way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fed and Fasted Conditions

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 53 days ]

Enrollment: 18
Study Start Date: April 1994
Study Completion Date: June 1994
Primary Completion Date: June 1994 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions.
Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions
Experimental: 2
Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.
Drug: Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions
Active Comparator: 3
Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.
Drug: Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913952


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: Richard Lalonde, Pharm.D. Phoenix International Life Science Inc.
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913952     History of Changes
Other Study ID Numbers: 940155
First Submitted: June 2, 2009
First Posted: June 4, 2009
Last Update Posted: March 28, 2017
Last Verified: June 2009

Keywords provided by Sandoz:
Antidepressant

Additional relevant MeSH terms:
Clomipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs