Bioequivalency Study of Sertraline Under Fed Conditions

NCT ID: NCT00601588

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2003-07-31

Brief Summary

The objective of this study was the bioequivalence of a Roxane Laboratories' Sertraline Tablets, 100 mg, to Zoloft® Tablets, 100 mg (Pfizer) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Sertraline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• Treatment with any triptan within 30 days prior to or during the study.
• History of allergic or adverse response to sertraline or any comparable or similar product.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roxane Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Roxane Laboratories, Inc.

Principal Investigators

Benoit Girard, MD

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Locations

Anapharm Inc.

Sainte-Fly, Quebec, Canada

Countries

Canada

Other Identifiers

SERT-02

Identifier Type: -

Identifier Source: org_study_id