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

NCT ID: NCT00944242

Last Updated: 2009-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

Brief 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.

Conditions

Healthy

Interventions

Sertraline

Intervention Type: DRUG

Sertraline Hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Torrent Pharmaceuticals Limited

INDUSTRY

Sponsor Role: lead

Locations

Anapharm Inc.

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

40485

Identifier Type: -

Identifier Source: org_study_id