Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Mylan Pharmaceuticals |
---|---|
Information provided by: | Mylan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00649532 |
The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fasting conditions.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Ondansetron Tablets 24 mg Drug: Zofran® Tablets 24 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 Ondansetron Tablets (24 mg; Mylan) and Zofran® Tablets (24 mg; GSK) in Healthy Volunteers |
Enrollment: | 28 |
Study Start Date: | July 2003 |
Study Completion Date: | July 2003 |
Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Ondansetron Tablets 24 mg
|
Drug: Ondansetron Tablets 24 mg
24mg, single dose fasting
|
2: Active Comparator
Zofran® Tablets 24 mg
|
Drug: Zofran® Tablets 24 mg
24mg, single dose fasting
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male 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, Missouri | |
Gateway Medical Research, Inc. | |
St. Charles, Missouri, United States, 63301 |
Principal Investigator: | Walter A Parham, M.D. | Cetero Research |
Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
Study ID Numbers: | ONDA-0313 |
Study First Received: | March 30, 2008 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00649532 |
Health Authority: | United States: Institutional Review Board |
Ondansetron Healthy Serotonin |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Antipsychotic Agents Pharmacologic Actions |
Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Antipruritics Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Dermatologic Agents |