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

Torrent Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Sertraline Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946036

40486

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) sertaline, administered as a 1X100 mg tablet, under fasted conditions.

• Study Design:

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

Sex

Volunteers: No Healthy Volunteers

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.