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

Primary Purpose

Nausea

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
EUR-1025
EUR-1025
EUR-1025
EUR-1025
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Ondansetron, EUR-1025

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Algorithme Pharma INc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

Regime 1

Regime 2

Regime 3

Regime 4

Arm Description

Regime 1 will be orally administered once daily in the morning over 6 consecutive days.

Regime 2 will be orally administered twice daily at 12 hours interval (morning and evening) over 6 consecutive days

Regime 3 will be orally administered three times daily at 8 hour intervals (morning, afternoon, evening) over 6 consecutive days.

Regime 4- Day 1- a single dose will be given. Day 2- one placebo capsule; Day 3- a single dose will be given . Day 4 & 5- two placebo capsules on each day; Day 6- a single does will be given.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 17, 2009
Last Updated
February 8, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01036854
Brief Title
Pharmacokinetic Study of Ondansetron Administered as IR (Zofran) and MR (EUR1025)
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea
Keywords
Ondansetron, EUR-1025

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regime 1
Arm Type
Experimental
Arm Description
Regime 1 will be orally administered once daily in the morning over 6 consecutive days.
Arm Title
Regime 2
Arm Type
Active Comparator
Arm Description
Regime 2 will be orally administered twice daily at 12 hours interval (morning and evening) over 6 consecutive days
Arm Title
Regime 3
Arm Type
Active Comparator
Arm Description
Regime 3 will be orally administered three times daily at 8 hour intervals (morning, afternoon, evening) over 6 consecutive days.
Arm Title
Regime 4
Arm Type
Experimental
Arm Description
Regime 4- Day 1- a single dose will be given. Day 2- one placebo capsule; Day 3- a single dose will be given . Day 4 & 5- two placebo capsules on each day; Day 6- a single does will be given.
Intervention Type
Drug
Intervention Name(s)
EUR-1025
Other Intervention Name(s)
Ondansetron
Intervention Description
orally, 24 mg, daily for 6 days
Intervention Type
Drug
Intervention Name(s)
EUR-1025
Other Intervention Name(s)
Ondansetron
Intervention Description
orally, 8 mg, twice daily over 6 consecutive days
Intervention Type
Drug
Intervention Name(s)
EUR-1025
Other Intervention Name(s)
Ondansetron
Intervention Description
orally, 8 mg, three times a day over 6 consecutive days
Intervention Type
Drug
Intervention Name(s)
EUR-1025
Other Intervention Name(s)
Ondansetron
Intervention Description
orally, 8 mg, 16 mg, 24 mg, daily, for 6 days
Primary Outcome Measure Information:
Title
Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay.
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Sicard, M.D.
Organizational Affiliation
Algorithme Pharma Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algorithme Pharma INc.
City
Mount-Royal
State/Province
Quebec
ZIP/Postal Code
H3P 3PI
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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