Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944242
• Other study ID #: 40485
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2009
• Last updated: July 22, 2009

Study information

• Verified date: July 2009
• Source: Torrent Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

• Objective:

• To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administered as a 1X100 mg tablet, under fasted conditions.

• Study Design:

• Single-dose, open-label, randomized two-way crossover.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

• Inclusion Criteria:

• Male or female, smoker or non smoker, 18 years of age and older.

• Capable of consent.

• BMI>= 19.0 and <30.0 kg/m2

• Exclusion Criteria:

Subjects to whom any of the following applies will be excluded from the study:

• Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication.

• Positive testing for hepatitis B, hepatitis C, or HIV at screening.

• ECG abnormalities or vital sign abnormalities(blood pressure).

• History of significant alcohol or drug abuse within one year prior to the screening visit.

• History or allergic reactions to heparin, sertraline or other related drugs.

• Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication.

• Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.

• History of seizures, suicide attempt, bipolar disorder or manic episodes.

• Depot injection or an implant of any drugs with in 6 months prior to administration of study medication.

• Breastfeeding subject.

• Positive urine pregnancy test at screening.

• female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration.

Acceptable methods of contraception:

1. Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration)

2. Condom or diaphragm + spermicide.

Study Design

N/A

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Sertraline

• Sertraline Hydrochloride

Locations

Country	Name	City	State
Canada	Anapharm Inc.	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Torrent Pharmaceuticals Limited

Country where clinical trial is conducted

Canada,