Bioequivalency Study of Sertraline Under Fed Conditions

• Status: Completed
• Trial end date: 2003-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Roxane Laboratories
• Treatments: Sertraline

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.