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

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea

Intervention: EUR-1025 (Drug); EUR-1025 (Drug); EUR-1025 (Drug); EUR-1025 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Eric Sicard, M.D., Principal Investigator, Affiliation: Algorithme Pharma Inc

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay.

Detailed 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.

Eligibility

Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.

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 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

Locations and Contacts

Algorithme Pharma INc., Mount-Royal, Quebec H3P 3PI, Canada
Additional Information

Starting date: February 2009
Last updated: December 17, 2009

Page last updated: August 23, 2015

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