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

NCT ID: NCT00871364

Last Updated: 2010-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2006-05-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

A

VENLAFAXINE TABLETS 50 mg, single dose

Group Type: EXPERIMENTAL

VENLAFAXINE TABLETS 50 mg , single dose

Intervention Type: DRUG

A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions

B

Effexor® (venlafaxine HCl) Tablets equivalent to 50 mg venlafaxine, single dose

Group Type: ACTIVE_COMPARATOR

Effexor® Tablets equivalent to 50 mg venlafaxine

Intervention Type: DRUG

B: Active comparator Subjects received Wyeth Pharmaceuticals Inc. formulated products under fed conditions

Interventions

VENLAFAXINE TABLETS 50 mg , single dose

A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions

Intervention Type: DRUG

Effexor® Tablets equivalent to 50 mg venlafaxine

B: Active comparator Subjects received Wyeth Pharmaceuticals Inc. formulated products under fed conditions

Intervention Type: DRUG

Other Intervention Names

venlafaxine; venlafaxine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Actavis Inc

Principal Investigators

Gaetano Morelli,, MD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

MDS Pharma Services

Saint-Laurent, Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

AA32215

Identifier Type: -

Identifier Source: org_study_id