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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: VENLAFAXINE TABLETS 50 mg , single dose; Drug: Effexor® Tablets equivalent to 50 mg venlafaxine

• Registration Number: NCT00871364
• Lead Sponsor: Actavis Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2006-04
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-13
• Last Update Posted: 2010-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	VENLAFAXINE TABLETS 50 mg , single dose	VENLAFAXINE TABLETS 50 mg, single dose
B	Effexor® Tablets equivalent to 50 mg venlafaxine	Effexor® (venlafaxine HCl) Tablets equivalent to 50 mg venlafaxine, single dose

Primary Outcome Measures

Name	Time	Method
Rate and Extend of Absorption	48 hours

Trial Locations

Locations (1)

MDS Pharma Services; 🇨🇦 Saint-Laurent, Montreal, Quebec, Canada