Back to resultsTo Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
Primary Purpose
Nausea, Vomiting
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
Sponsored by
About this trial
This is an interventional treatment trial for Nausea focused on measuring Antiemetic
Eligibility Criteria
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
Outcomes
Primary Outcome Measures
Bioequivalence based on AUC and Cmax
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00947128
Brief Title
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
Official Title
A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sandoz
4. Oversight
5. Study Description
Brief Summary
To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under non-fasting conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Antiemetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
Intervention Type
Drug
Intervention Name(s)
Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
Intervention Type
Drug
Intervention Name(s)
Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)
Primary Outcome Measure Information:
Title
Bioequivalence based on AUC and Cmax
Time Frame
9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
Positive test results for HIV or hepatitis B or C.
Treatment for drug or alcohol dependence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soran Hong, M.D.
Organizational Affiliation
Novum Pharmaceutical Research Services
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions
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