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

Phase 1CompletedNCT00946387

Sandoz26 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nausea Vomiting

Interventions

Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)DRUG

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

Eligibility

Sex: ALLMin age: 22 YearsMax age: 58 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time frame: 9 days

Data from ClinicalTrials.gov

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