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Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)

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ClinicalTrials.gov Identifier: NCT00972595
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : June 22, 2010
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Chemotherapy-Induced Nausea and Vomiting Drug: ondansetron clinical trial formulation Drug: ondansetron marketed formulation Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : June 2004
Primary Completion Date : August 2004
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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™



Primary Outcome Measures :
  1. 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 ]
  2. Peak Plasma Concentration (Cmax) for Ondansetron [ Time Frame: 24 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972595


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00972595     History of Changes
Other Study ID Numbers: 0869-106
MK0869-106
2009_657
First Posted: September 7, 2009    Key Record Dates
Results First Posted: June 22, 2010
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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