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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00972595
First received: September 3, 2009
Last updated: May 12, 2014
Last verified: May 2014

September 3, 2009
May 12, 2014
June 2004
August 2004   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Peak Plasma Concentration (Cmax) for Ondansetron [ Time Frame: 24 hours post-dose ] [ Designated as safety issue: No ]
  • Area under the concentration versus time curve (AUC(0-infinity) for ondansetron [ Time Frame: Through 24 hours post-dose ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of ondansetron [ Time Frame: Through 24 hours post-dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00972595 on ClinicalTrials.gov Archive Site
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Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
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

This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Chemotherapy-Induced Nausea and Vomiting
  • Drug: ondansetron clinical trial formulation
    Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.
    Other Name: ZOFRAN™
  • Drug: ondansetron marketed formulation
    Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
    Other Name: ZOFRAN™
  • Experimental: A
    clinical trial formulation
    Intervention: Drug: ondansetron clinical trial formulation
  • Active Comparator: B
    non-U.S. marketed formulation
    Intervention: Drug: ondansetron marketed formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
September 2004
August 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00972595
0869-106, MK0869-106, 2009_657
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP