Venlafaxine Hydrochloride 150 mg Extended-Release Capsules Sprinkle Study

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01282814
First received: January 24, 2011
Last updated: February 11, 2011
Last verified: February 2011
  Purpose

The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg capsules (test) versus Effexor® XR (reference) administered as the content of 1 x 150 mg extended-release capsule mixed with applesauce 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 the Content of 1 x 150 mg Extended-Release Capsule Mixed With Applesauce 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 48 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 48 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 48 hour period. ] [ Designated as safety issue: No ]
    Bioequivalence based on Venlafaxine AUC0-inf (area under the concentration-time curve from time zero to infinity).


Enrollment: 24
Study Start Date: February 2003
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Test Product
Venlafaxine Hydrochloride 150 mg Extended-Release Capsules.
Drug: Venlafaxine Hydrochloride
150 mg Extended-Release Capsule
Active Comparator: Reference Listed Drug
Effexor® XR 150 mg Extended-Release Capsules
Drug: Effexor® XR
150 mg Extended-Release Capsule
Other Name: Venlafaxine 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 of age and older.
  • Female subjects will be postmenopausal 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 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 greater than 30.0.
  • History of significant alcohol abuse within 6 months of the screening visit or any indication of the regular use of more than 14 units of alcohol per week (1 unit is equal to 150 mL of wine, 360mL 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, crack) within 1 year of the screening visit.
  • History of allergic reactions to venlafaxine.
  • History of allergic reactions to heparin.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication.
  • Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • 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.
  • Any history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
  • 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 exposure.
  • Positive alcohol breath test at screening.
  • Subjects who have used tobacco in any form within the 90 days preceding study drug administration.
  • Any food allergies, intolerance, restriction, or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
  • Subjects who have had a depot injection or implant of any drug 3 months prior to 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.
  • Subjects who have consumed food or beverages containing grapefruit within 7 days prior to administration of the study medication.
  • Subjects with clinically significant presence or history of raised intra-ocular pressure or at the risk of acute narrow angle glaucoma.
  • Subjects who have dentures or braces.
  • Intolerance to venipunctures.
  • Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, or psychosis will not be eligible for this study.
  • Subjects who are unable to understand or unwilling to sign the Informed Consent Form.
  • Subjects with the known presence of volume-depletion.
  • Subjects predisposed to bleeding of the skin and mucous membrane (impaired platelet aggregation).
  • Subjects with clinically significant history of seizures.
  • Additional exclusion criteria for females only:

    • Breastfeeding subjects.
    • Positive urine pregnancy test screen 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: NCT01282814

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: NCT01282814     History of Changes
Other Study ID Numbers: 30024
Study First Received: January 24, 2011
Results First Received: February 11, 2011
Last Updated: February 11, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

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

ClinicalTrials.gov processed this record on October 19, 2014