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
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