Bioequivalency Study of Sertraline Under Fasting Conditions

• Sponsor: Roxane Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00602849
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Duration (Days): 30
• Patients Per Site Per Month: 38.6

Study Details

Study Description

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 fasting conditions using a single-dose, 2-treatment, 2-period, crossover design.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Sertraline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Sertraline Tablets 100 mg Under Fasting Conditions
• Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: Jul 1, 2003
• Actual Study Completion Date: Jul 1, 2003

Outcome Measures

Primary Outcome Measures

1. Bioequivalence [Baseline, Two period, Fourteen day washout]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anapharm Inc.	Sainte-Fly	Quebec	Canada

Sponsors and Collaborators

• Roxane Laboratories

Investigators

• Principal Investigator: Benoit Girard, MD, Anapharm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00602849
• Other Study ID Numbers: SERT-01
• First Posted: Jan 28, 2008
• Last Update Posted: Jan 23, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Depression; Sertraline

Study Results

No Results Posted as of Jan 23, 2018