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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971633
First Posted: September 4, 2009
Last Update Posted: September 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
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

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 ]
  • Maximum Plasma Concentration (Cmax) of Ondansetron [ Time Frame: 24 hours post dose ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00971633     History of Changes
Other Study ID Numbers: 0869-095
2009_656
First Submitted: September 3, 2009
First Posted: September 4, 2009
Results First Submitted: July 30, 2010
Results First Posted: August 26, 2010
Last Update Posted: September 14, 2016
Last Verified: September 2016

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