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A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00971633
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : August 26, 2010
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Nausea and Vomiting Drug: Comparator: Treatment A (Zofran, ondansetron) Drug: Comparator: Treatment B (Zofran, ondansetron) Drug: Comparator: Treatment C (Zofran, ondansetron) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Single Dose, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
Study Start Date : November 2003
Actual Primary Completion Date : December 2003
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Treatment Sequence A-B-C
 Drug: Comparator: Treatment A (Zofran, ondansetron)
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment B (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment C (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Name: Zofran, ondansetron
Experimental: 2
Treatment Sequence B-C-A
 Drug: Comparator: Treatment A (Zofran, ondansetron)
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment B (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment C (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Name: Zofran, ondansetron
Experimental: 3
Treatment Sequence C-A-B
 Drug: Comparator: Treatment A (Zofran, ondansetron)
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment B (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment C (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Name: Zofran, ondansetron
Experimental: 4
Treatment Sequence A-C-B
 Drug: Comparator: Treatment A (Zofran, ondansetron)
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment B (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment C (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Name: Zofran, ondansetron
Experimental: 5
Treatment Sequence B-A-C
 Drug: Comparator: Treatment A (Zofran, ondansetron)
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment B (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment C (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Name: Zofran, ondansetron
Experimental: 6
Treatment Sequence C-B-A
 Drug: Comparator: Treatment A (Zofran, ondansetron)
an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment B (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the U.K., taken PO
Other Name: Zofran, ondansetron

Drug: Comparator: Treatment C (Zofran, ondansetron)
a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Other Name: Zofran, ondansetron


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose ]
  2. Maximum Plasma Concentration (Cmax) of Ondansetron [ Time Frame: 24 hours post dose ]

Eligibility Criteria
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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 is a nonsmoker
  • Subject is in good general health

Exclusion Criteria:

  • Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease
  • Subject is taking prescription or nonprescription drugs that can not be discontinued during the study
  • Subject is a habitual and heavy consumer of caffeine
Contacts and Locations
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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): NCT00971633


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00971633    
Other Study ID Numbers: 0869-095
2009_656
First Posted: September 4, 2009    Key Record Dates
Results First Posted: August 26, 2010
Last Update Posted: September 14, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
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