Pharmacokinetic Study of Ondansetron Administered as IR (Zofran) and MR (EUR1025)

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

• Male and female volunteers

• Non- or ex-smokers

• At least 21 years of age but not older than 55 years

• Body mass index targeted to be at least 18.5 and less than 30 kg/m2.

• Acceptable lab tests

• Normal 12 lead ECG

• Negative human chorionic gonadotropin (hCG) for females.

Exclusion Criteria:

• No known hypersensitivity to Ondansetron or any related products

• No presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption

• No presence of significant heart disease or disorder discovered on screening ECG

• Not pregnant

• No alcohol or drug abuse history

• No use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP)

• No previous Investigational Product (in another clinical trial) or donated 50 ml or more of blood in the previous 28 days before day 1 of this study