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

Primary Purpose

Chemotherapy-Induced Nausea and Vomiting

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ondansetron clinical trial formulation
ondansetron marketed formulation
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 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    A

    B

    Arm Description

    clinical trial formulation

    non-U.S. marketed formulation

    Outcomes

    Primary Outcome Measures

    Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron
    Peak Plasma Concentration (Cmax) for Ondansetron

    Secondary Outcome Measures

    Full Information

    First Posted
    September 3, 2009
    Last Updated
    August 18, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00972595
    Brief Title
    Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    August 2004 (Actual)
    Study Completion Date
    September 2004 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    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.

    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
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    clinical trial formulation
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    non-U.S. marketed formulation
    Intervention Type
    Drug
    Intervention Name(s)
    ondansetron clinical trial formulation
    Other Intervention Name(s)
    ZOFRAN™
    Intervention Description
    Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
    Intervention Type
    Drug
    Intervention Name(s)
    ondansetron marketed formulation
    Other Intervention Name(s)
    ZOFRAN™
    Intervention Description
    Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
    Primary Outcome Measure Information:
    Title
    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
    Title
    Peak Plasma Concentration (Cmax) for 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 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
    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

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

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