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

Torrent Pharmaceuticals Limited1 个研究点分布在 1 个国家开始时间: 2009年7月23日最近更新: 2009年7月23日

适应症

试验速览

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.

•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:
•Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration)
•Condom or diaphragm + spermicide.

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