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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Vomiting; Nausea

Treatments: Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline); Drug: Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946387

B043712

Details and patient eligibility

About

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

Enrollment: 26 patients

Sex: All

Ages: 22 to 58 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

1

Experimental group

Description:

Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)

Treatment:

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

2

Active Comparator group

Description:

Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

Treatment:

Drug: Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)