Clinical trial NCT00871364: A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
venlafaxine
Healthy subjects
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

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.

Primary outcomes:
measure: Rate and Extend of Absorption
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Laurent, Montreal
country: Canada
facility: MDS Pharma Services
state: Quebec
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli,, MD
role: PRINCIPAL_INVESTIGATOR
References: