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

Phase 1

Completed

• Conditions: Nausea; Vomiting
• Interventions: Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.); Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

• Registration Number: NCT00947128
• Lead Sponsor: Sandoz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)	Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)
2	Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)	Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	9 days