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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: VENLAFAXINE TABLETS 50 mg , single dose; Drug: Effexor® Tablets equivalent to 50 mg 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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Saint-Laurent, Montreal, Quebec, Canada, H4R 2N6
      • MDS Pharma Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: venlafaxine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	48 hours

Collaborators and Investigators

• Sponsor: Actavis Inc.
• Investigators: Principal Investigator: Gaetano Morelli,, MD, MDS Pharma Services

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): May 1, 2006
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: March 26, 2009
• First Submitted That Met QC Criteria: March 27, 2009
• First Posted (Estimate): March 30, 2009

Study Record Updates

• Last Update Posted (Estimate): August 16, 2010
• Last Update Submitted That Met QC Criteria: August 13, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy subjects; venlafaxine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: AA32215