Healthy
Conditions
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.
Interventions
DRUGSertraline
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion 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.
Countries
Canada
Outcome results
None listed