Bioequivalence of Two Formulations of Ondansetron in Healthy Adults
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00972595
First received: September 3, 2009
Last updated: June 22, 2010
Last verified: June 2010
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Purpose
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapy-Induced Nausea and Vomiting |
Drug: ondansetron clinical trial formulation Drug: ondansetron marketed formulation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose ] [ Designated as safety issue: No ]
- Peak Plasma Concentration (Cmax) for Ondansetron [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | June 2004 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
clinical trial formulation
|
Drug: ondansetron clinical trial formulation
Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
Other Name: ZOFRAN™
|
|
Active Comparator: B
non-U.S. marketed formulation
|
Drug: ondansetron marketed formulation
Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
Other Name: ZOFRAN™
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- If female, subject is not pregnant or breast-feeding
- Subject has been a nonsmoker for at least 6 months
- Subject is in good health
Exclusion Criteria:
- Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease
- Subject is a habitual and heavy consumer of caffeine
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00972595 History of Changes |
| Other Study ID Numbers: | 2009_657, MK0869-106 |
| Study First Received: | September 3, 2009 |
| Results First Received: | May 19, 2010 |
| Last Updated: | June 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Vomiting Signs and Symptoms, Digestive Signs and Symptoms 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 |
ClinicalTrials.gov processed this record on June 18, 2013