Status:
COMPLETED
A Relative Bioavailability Study of 50 mg Venlafaxine Hydrochloride Tablets Under Fed Conditions
Lead Sponsor:
Actavis Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ven...
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 Gro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00871364
Start Date
April 1 2006
End Date
May 1 2006
Last Update
August 16 2010
Active Locations (1)
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1
MDS Pharma Services
Saint-Laurent, Montreal, Quebec, Canada, H4R 2N6