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

A

Actavis

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: VENLAFAXINE TABLETS 50 mg , single dose
Drug: Effexor® Tablets equivalent to 50 mg venlafaxine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00871364
AA32215

Details and patient eligibility

About

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.

Full 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

Enrollment

30 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

A
Experimental group
Description:
VENLAFAXINE TABLETS 50 mg, single dose
Treatment:
Drug: VENLAFAXINE TABLETS 50 mg , single dose
B
Active Comparator group
Description:
Effexor® (venlafaxine HCl) Tablets equivalent to 50 mg venlafaxine, single dose
Treatment:
Drug: Effexor® Tablets equivalent to 50 mg venlafaxine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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