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

NCT00871364 | Completed Phase 1

• 1 other identifier: AA32215
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; venlafaxine; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  48 hours

Study Arms (2)

A

EXPERIMENTAL

VENLAFAXINE TABLETS 50 mg, single dose

Drug: VENLAFAXINE TABLETS 50 mg , single dose

B

ACTIVE COMPARATOR

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

Drug: Effexor® Tablets equivalent to 50 mg venlafaxine

Interventions

VENLAFAXINE TABLETS 50 mg , single dose DRUG

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

Also known as: venlafaxine

A

Effexor® Tablets equivalent to 50 mg venlafaxine DRUG

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

Also known as: venlafaxine

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• mL of blood in 14 days; or
• mL of blood in 180 days; or
• mL of blood in 1 year.

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

MDS Pharma Services

Saint-Laurent, Montreal, Quebec, H4R 2N6, Canada

Location

MeSH Terms

Interventions

Venlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Gaetano Morelli,, MD

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: April 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

CA (1)