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

Torrent Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Sertraline; Drug: Sertraline Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944242

40485

Details and patient eligibility

About

• 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.