Single-Dose Food In Vivo Bioequivalence Study of Sertraline Hydrochloride Tablets (100 mg; Mylan) and Zoloft® Tablets (100 mg; Pfizer) in Healthy Volunteers

Mylan Pharmaceuticals Inc1 site in 1 country21 target enrollmentDecember 2002

ConditionsHealthy

InterventionsSertraline Hydrochloride Tablets 100 mg Zoloft® Tablets 100 mg

DrugsSertraline Hydrochloride Tablets 100 mg Zoloft® Tablets 100 mg

Overview

Phase: Phase 1
Intervention: Sertraline Hydrochloride Tablets 100 mg
Conditions: Healthy
Sponsor: Mylan Pharmaceuticals Inc
Enrollment: 21
Locations: 1
Primary Endpoint: Bioequivalence
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fed conditions.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

January 2003

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Mylan Pharmaceuticals Inc

Eligibility Criteria

Inclusion Criteria

•Age: 18 years and older.
•Sex: Male and/or non-pregnant, non-lactating female.
•Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on weekends, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (beta-HCG) pregnancy test will be performed upon completion of the study.
•Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
•hormonal contraceptives initiated at least 3 months prior to the start of the study and continued during the study, or
•intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
•barrier methods containing or used in conjunction with a spermicidal agent, or
•surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
•During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.
•Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).

Exclusion Criteria

•Institutionalized subjects will not be used.
•Social Habits:
•Use of any tobacco products.
•Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
•Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
•Any recent, significant change in dietary or exercise habits.
•Positive test for any drug included in the urine drug screen.
•Medications:
•Use of any medication within the 14 days prior to the initial dose of study medication, excluding hormonal contraceptives and hormonal replacement therapy initiated at least 3 months prior to study medication dosing.
•Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication, excluding hormonal contraceptives and hormonal replacement therapy initiated at least 3 months prior to study medication dosing.