a relative bioavailability study of 50 mg venlafaxine hydrochloride tablets under fed conditions

Conditions: Healthy

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.

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 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.

Keywords: bioequivalence venlafaxine healthy subjects