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

Nausea Clinical Trial

Official title:

Parallel, Group, Laboratory-Blinded, Single and Multiple-dose Pharmacokinetic Study of Ondansetron Administered as the Immediate-Release (Zofran) and Modified-Release (EUR1025) Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01036854
• Other study ID #: ODO-P8-690
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2009
• Last updated: February 8, 2017
• Start date: February 2009
• Est. completion date: April 2009

Study information

• Verified date: February 2017
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron administered as a novel modified-release formulation (EUR1025 24 mg) as well as the immediate-release formulation (Zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. The safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea

Intervention

Drug:
• EUR-1025
orally, 24 mg, daily for 6 days
• EUR-1025
orally, 8 mg, twice daily over 6 consecutive days
• EUR-1025
orally, 8 mg, three times a day over 6 consecutive days
• EUR-1025
orally, 8 mg, 16 mg, 24 mg, daily, for 6 days

Locations

Country	Name	City	State
Canada	Algorithme Pharma INc.	Mount-Royal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay.		6 days