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

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: Treatment A (Zofran, ondansetron)
Comparator: Treatment B (Zofran, ondansetron)
Comparator: Treatment C (Zofran, ondansetron)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-Induced Nausea and Vomiting

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    5

    6

    Arm Description

    Treatment Sequence A-B-C

    Treatment Sequence B-C-A

    Treatment Sequence C-A-B

    Treatment Sequence A-C-B

    Treatment Sequence B-A-C

    Treatment Sequence C-B-A

    Outcomes

    Primary Outcome Measures

    Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron
    Maximum Plasma Concentration (Cmax) of Ondansetron

    Secondary Outcome Measures

    Full Information

    First Posted
    September 3, 2009
    Last Updated
    September 13, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00971633
    Brief Title
    A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    January 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-Induced Nausea and Vomiting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Treatment Sequence A-B-C
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Treatment Sequence B-C-A
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Treatment Sequence C-A-B
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    Treatment Sequence A-C-B
    Arm Title
    5
    Arm Type
    Experimental
    Arm Description
    Treatment Sequence B-A-C
    Arm Title
    6
    Arm Type
    Experimental
    Arm Description
    Treatment Sequence C-B-A
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Treatment A (Zofran, ondansetron)
    Other Intervention Name(s)
    Zofran, ondansetron
    Intervention Description
    an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO)
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Treatment B (Zofran, ondansetron)
    Other Intervention Name(s)
    Zofran, ondansetron
    Intervention Description
    a single 8 mg tablet of Zofran marketed in the U.K., taken PO
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Treatment C (Zofran, ondansetron)
    Other Intervention Name(s)
    Zofran, ondansetron
    Intervention Description
    a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
    Primary Outcome Measure Information:
    Title
    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
    Title
    Maximum Plasma Concentration (Cmax) of Ondansetron
    Time Frame
    24 hours post dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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