Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
- Objective: - To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions. - Study Design: - Single-dose, open-label, randomized two-way crossover.
Phase:
Phase 1
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Sertraline
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:

- 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.