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NCT00947128 Clinical Trial

To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions

Nausea Clinical Trial

Official title:
A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Non-Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00947128
Other study ID # B043713
Secondary ID
Status Completed
Phase Phase 1
First received July 24, 2009
Last updated March 27, 2017
Start date September 2004
Est. completion date October 2004

Study information
Verified date July 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under non-fasting conditions.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 58 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)

• Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sandoz

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence based on AUC and Cmax 9 days
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