Bioequivalency Study of Sertraline Under Fasting Conditions

Roxane Laboratories

Status: Completed

Conditions: Depression

Treatments: Drug: Sertraline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00602849

SERT-01

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)