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Sponsored by: |
Mylan Pharmaceuticals |
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Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00650325 |
The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Sertraline Hydrochloride Tablets 100 mg Drug: Zoloft® Tablets 100 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Sertraline Hydrochloride Tablets (100 mg; Mylan) and Zoloft® Tablets (100 mg; Pfizer) in Healthy Volunteers |
Enrollment: | 49 |
Study Start Date: | November 2002 |
Study Completion Date: | December 2002 |
Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Sertraline Hydrochloride Tablets 100 mg
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Drug: Sertraline Hydrochloride Tablets 100 mg
100mg, single dose fasting
|
2: Active Comparator
Zoloft® Tablets 100 mg
|
Drug: Zoloft® Tablets 100 mg
100mg, single dose fasting
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
United States, West Virginia | |
Kendle International Inc. | |
Morgantown, West Virginia, United States, 26505 |
Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | SERT-0224 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00650325 |
Health Authority: | United States: Institutional Review Board |
Sertraline Healthy Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |