Skip to main content
OpenTrials
Completed

NCT Number: NCT00947128

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ondansetron HCl 24 mg Tablets (Sandoz, Inc.)

Drug

Zofran (Ondansetron HCl) 24 mg Tablets (GlaxoSmithKline)

Drug

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jul 27, 2009
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.