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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648583 |
Purpose
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 fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Ondansetron Tablets 24 mg Drug: Zofran® Tablets 24 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Single-Dose Food 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 |
|---|---|
|
Experimental: 1
Ondansetron Tablets 24 mg
|
Drug: Ondansetron Tablets 24 mg
24mg, single dose fed
|
|
Active Comparator: 2
Zofran® Tablets 24 mg
|
Drug: Zofran® Tablets 24 mg
24mg, single dose fed
|
Eligibility| 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:
Contacts and Locations| United States, Missouri | |
| Gateway Medical Research, Inc. | |
| St. Charles, Missouri, United States, 63301 | |
| Principal Investigator: | Steven Herrmann, M.D., Ph.D. | Cetero Research, San Antonio |
More Information
| Responsible Party: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00648583 History of Changes |
| Other Study ID Numbers: | ONDA-0314 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Ondansetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antipruritics |
Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents |