Healthy
Conditions
Keywords
Bioequivalence, venlafaxine, Healthy subjects
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
Interventions
DRUGVENLAFAXINE TABLETS 50 mg , single dose
A: Experimental Subjects received EMCURE PHARMACEUTICALS LTD. formulated products under fed conditions
DRUGEffexor® Tablets equivalent to 50 mg venlafaxine
B: Active comparator Subjects received Wyeth Pharmaceuticals Inc. formulated products under fed conditions
Sponsors
Actavis Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate and Extend of Absorption | 48 hours |
Countries
Canada
Outcome results
None listed