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

Information source: Actavis Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: VENLAFAXINE TABLETS 50 mg , single dose (Drug); Effexor® Tablets equivalent to 50 mg venlafaxine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Actavis Inc.

Official(s) and/or principal investigator(s):
Gaetano Morelli,, MD, Principal Investigator, Affiliation: MDS Pharma Services

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Rate and Extend of Absorption

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

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

VENLAFAXINE

Starting date: April 2006
Last updated: August 13, 2010

Page last updated: August 23, 2015

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