A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Non-fasting Conditions

NCT ID: NCT00864019

Last Updated: 2010-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2004-08-31

Brief Summary

To compare the rate of absorption and oral bioavailability of a test formulation of Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer Inc. Following an overnight fast of at least 10 hours, subjects will consume a standard high-calorie, high-fat breakfast meal. This standard breakfast will begin 30 minutes prior to each dose.

Detailed Description

Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period crossover study

Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Sertraline 100 mg Tablets Under Fed Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

A

Sertraline HCl 100 mg tablets, single dose

Group Type: EXPERIMENTAL

Sertraline HCl 100 mg tablets, single dose

Intervention Type: DRUG

A: Experimental SSubjects received Purepac formulated products under non-fasting conditions

B

Zoloft® 100 mg tablets, single dose

Group Type: ACTIVE_COMPARATOR

Zoloft® 100 mg tablets, single dose

Intervention Type: DRUG

B: Active comparator Subjects received Pfizer formulated products under non-fasting conditions

Interventions

Sertraline HCl 100 mg tablets, single dose

A: Experimental SSubjects received Purepac formulated products under non-fasting conditions

Intervention Type: DRUG

Zoloft® 100 mg tablets, single dose

B: Active comparator Subjects received Pfizer formulated products under non-fasting conditions

Intervention Type: DRUG

Other Intervention Names

Sertraline; Sertraline

Eligibility Criteria

Inclusion Criteria

• Subject must be a male or non-pregnant, non-breast-feeding female.
• Subject must be between 18 and 55 years of age inclusive.
• Subject's body weight should be within ±15% of the ideal body weight for their height and estimated frame based on the Metropolitan Life Insurance Company Table.
• Female subjects --- not surgically sterile or at least two years postmenopausal --- must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection), double barrier (condom and diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
• Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
• Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return to the study site for all out-patient visits.

Exclusion Criteria

• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
• Has a clinically significant abnormal finding on the physical exam, medical history or clinical laboratory results at screening.
• History or presence of allergic or adverse response to the study drug or related drugs.
• Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
• Has donated blood or plasma within 30 days prior to the first dose of study medication.
• Has participated in another clinical trial within 30 days prior to first dose of study medication.
• Has used any over-the-counter (OTC) medication including vitamins, within 7 days prior to the first dose of study medication.
• Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 7 days prior to the first dose of study medication.
• Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
• Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
• Female with a positive pregnancy test.
• Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
• Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Actavis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Actavis Inc

Principal Investigators

Daniel V. Freeland,, D.O., CCI

Role: PRINCIPAL_INVESTIGATOR

CEDRA Clinical Research, LLC

Locations

CEDRA Clinical Research, LLC

Austin, Texas, United States

Countries

United States

Other Identifiers

20-683-1G

Identifier Type: -

Identifier Source: org_study_id