A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00871364
First received: March 26, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

The purpose of this study to assess the single-dose relative bioavailability of Actavis Group hf 50 mg venlafaxine hydrochloride tablets with Wyeth Pharmaceuticals (Effexor®) 50 mg venlafaxine (as venlafaxine hydrochloride) tablets under fed conditions.


Condition Intervention Phase
Healthy
Drug: VENLAFAXINE TABLETS 50 mg , single dose
Drug: Effexor® Tablets equivalent to 50 mg venlafaxine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf 50 mg Venlafaxine Hydrochloride Tablets and Wyeth Pharmaceuticals (Effexor®) 50 mg Venlafaxine Hydrochloride Tablets

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
VENLAFAXINE TABLETS 50 mg, single dose
Drug: VENLAFAXINE TABLETS 50 mg , single dose
A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions
Other Name: venlafaxine
Active Comparator: B
Effexor® (venlafaxine HCl) Tablets equivalent to 50 mg venlafaxine, single dose
Drug: Effexor® Tablets equivalent to 50 mg venlafaxine
B: Active comparator Subjects received Wyeth Pharmaceuticals Inc. formulated products under fed conditions
Other Name: venlafaxine

Detailed Description:

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Actavis Group hf 50 mg Venlafaxine Hydrochloride Tablets and Wyeth Pharmaceuticals (Effexor®) 50 mg Venlafaxine Hydrochloride Tablets in Healthy Adult Volunteers under Fed Conditions.

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult male or female volunteers, 18-55 years of age.
  • Weighing at least 60 kg for males and 52 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
  • Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs.
  • Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study and for 6 days following the last dose or were using one of the following acceptable birth control methods:

    • surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum;
    • IUD in place for at least 3 months;
    • barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study and for 6 days following the last dose;
    • surgical sterilization of the partner (vasectomy for 6 months minimum);
    • hormonal contraceptives for at least 3 months prior to the first dose of the study and up to 6 days following the last dose. Other birth control methods may have been deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years were eligible.
  • Gave voluntary written informed consent to participate in the study.

Exclusion Criteria:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
  • In addition, history or presence of:

    • alcoholism or drug abuse within the past year;
    • hypersensitivity or idiosyncratic reaction to venlafaxine or other selective serotonin and norepinephrine reuptake inhibitors;
    • glaucoma.
  • Female subjects who were pregnant or lactating.
  • Subjects who tested positive at screening for HIV, HbsAg or HCV.
  • Subjects who received monoamine oxidase (MAO) inhibitors within 28 days prior to dosing.
  • Subjects who used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as P450 enzymes) within 10 days prior to the first dose.
  • Subjects who used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as P450 enzymes) within 28 days prior to the first dose.
  • Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to the first dose.
  • Subjects who, through completion of the study, would have donated in excess of:

    • 500 mL of blood in 14 days; or
    • 1500 mL of blood in 180 days; or
    • 2500 mL of blood in 1 year.
  • Subjects whose PR interval is >200 msec at screening and prior to dosing.
  • Subjects whose QTc interval is >450 msec at screening and prior to dosing.
  • Subjects who completed another clinical trial within 28 days prior to the first dose.
  • Subjects who were on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
  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: NCT00871364

Locations
Canada, Quebec
MDS Pharma Services
Saint-Laurent, Montreal, Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: Gaetano Morelli,, MD MDS Pharma Services
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00871364     History of Changes
Other Study ID Numbers: AA32215
Study First Received: March 26, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
venlafaxine
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 September 18, 2014