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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00971633
First received: September 3, 2009
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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 Intervention 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 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, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) of Ondansetron [ Time Frame: 24 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2003
Study Completion Date: January 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971633

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

Additional Information:
No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00971633     History of Changes
Other Study ID Numbers: 2009_656, MK0869-095
Study First Received: September 3, 2009
Results First Received: July 30, 2010
Last Updated: July 30, 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 April 16, 2014