Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01260896
First received: December 14, 2010
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg extended-release capsules (test) versus Effexor® XR (reference) administered as 1 x 150 mg extended-release capsule under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Venlafaxine Hydrochloride
Drug: Effexor® XR
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, 2-way Crossover, Bioequivalence Study of Venlafaxine Hydrochloride 150 mg Extended-Release Capsules and Effexor® XR 150 mg Extended-Release Capsules Administered as 1 x 150 mg Extended-Release Capsule in Healthy Subjects Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax of Venlafaxine. [ Time Frame: Blood samples collected over a 36 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Venlafaxine Cmax (maximum observed concentration of drug substance in plasma).

  • AUC0-t of Venlafaxine. [ Time Frame: Blood samples collected over a 36 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Venlafaxine AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).

  • AUC0-inf of Venlafaxine. [ Time Frame: Blood samples collected over a 36 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).


Secondary Outcome Measures:
  • Cmax of O-Desmethylvenlafaxine. [ Time Frame: Blood samples collected over a 36 hour period. ] [ Designated as safety issue: No ]
    Informational comparison of Cmax values for the metabolite O-Desmethylvenlafaxine.

  • AUC0-t of O-Desmethylvenlafaxine. [ Time Frame: Blood samples collected over a 36 hour period. ] [ Designated as safety issue: No ]
    Informational comparison of AUC0-t values for the metabolite O-Desmethylvenlafaxine.

  • AUC0-inf of O-Desmethylvenlafaxine. [ Time Frame: Blood samples collected over a 36 hour period. ] [ Designated as safety issue: No ]
    Informational comparison of AUC0-inf values for the metabolite O-Desmethylvenlafaxine.


Enrollment: 24
Study Start Date: September 2002
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Test Product
150 mg Venlafaxine Hydrochloride Extended-Release Capsules
Drug: Venlafaxine Hydrochloride
150 mg Extended-Release Capsule
Active Comparator: Reference Listed Drug
150 mg Effexor® XR Extended-Release Capsules
Drug: Effexor® XR
150 mg Extended-Release Capsule
Other Name: Velafaxine Hydrochloride (generic name)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Members of the community at large.
  • Subjects will be females and/or males, non-smokers, 18 years or age and older.
  • Female subjects will be post-menopausal or surgically sterilized.

Exclusion Criteria:

  • Clinically significant illness within 4 weeks of the administration of study medication.
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any clinically significant abnormality found during medical screening.
  • Any history or presence of significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
  • History or presence of any clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Subjects with raised intra-ocular pressure or at risk of acute narrow angle glaucoma.
  • Subjects predisposed to bleeding of the skin and mucous membrane.
  • Subjects with a history of seizures.
  • Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant.
  • Positive urine drug screen at screening.
  • Positive testing for hepatitis B, hepatitis C, or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities at screening.
  • Subjects with BMI > 30.0.
  • History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 unit = 150 mL of wine, or 360 mL of beer, or 45 mL of alcohol 40%).
  • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, PCP, and crack) within 1 year of the screening visit.
  • Any food allergy, intolerance, restriction, or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in the study.
  • History of allergic reaction to venlafaxine hydrochloride.
  • History of allergic reaction to heparin.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism, use of any investigational drug, or participation in an investigational study within 30 days prior to administration of the study medication.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Subjects who have had a depot injection or an implant of any drug 3 months prior to the administration of study medication.
  • Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:

    • less than 300 mL of whole blood within 30 days, or
    • 300 mL to 500 mL of whole blood within 45 days, or
    • more than 500 mL of whole blood within 56 days.
  • Positive alcohol breath test at screening.
  • Subjects who have used tobacco in any form within the 90 days preceding study drug administration.
  • Subjects who have consumed food or beverages containing grapefruit within 7 days prior to administration of the study medication.
  • Intolerance to venipunctures.
  • Additional exclusion criteria for females only:

    • Breast-feeding subjects.
    • Positive urine pregnancy test at screening.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260896

Locations
Canada, Quebec
Anapharm Inc.
Sainte-Foy, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Benoit Girard, M.D. Anapharm
  More Information

No publications provided

Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT01260896     History of Changes
Other Study ID Numbers: 02204
Study First Received: December 14, 2010
Results First Received: January 24, 2011
Last Updated: January 24, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014