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”

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 Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: May 2006

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

Intervention(s) in this Clinical Trial

• Drug: VENLAFAXINE TABLETS 50 mg , single dose
  • A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions
• Drug: Effexor® Tablets equivalent to 50 mg venlafaxine
  • B: Active comparator Subjects received Wyeth Pharmaceuticals Inc. formulated products under fed conditions

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • VENLAFAXINE TABLETS 50 mg, single dose
• Active Comparator: B
  • Effexor® (venlafaxine HCl) Tablets equivalent to 50 mg venlafaxine, single dose

Primary Measures

• Rate and Extend of Absorption
  • Time Frame: 48 hours
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Actavis Inc.

Overall Clinical Trial Officials and Contacts

Gaetano Morelli,, MD Principal Investigator MDS Pharma Services  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00871364

Study ID Number: AA32215

ClinicalTrials.gov Identifier: NCT00871364

Health Authority: United States: Institutional Review Board

VENLAFAXINE