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

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ClinicalTrials.gov Identifier: NCT01036854
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Nausea Drug: EUR-1025 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Regime 1
Regime 1 will be orally administered once daily in the morning over 6 consecutive days.
Drug: EUR-1025
orally, 24 mg, daily for 6 days
Other Name: Ondansetron
Active Comparator: Regime 2
Regime 2 will be orally administered twice daily at 12 hours interval (morning and evening) over 6 consecutive days
Drug: EUR-1025
orally, 8 mg, twice daily over 6 consecutive days
Other Name: Ondansetron
Active Comparator: Regime 3
Regime 3 will be orally administered three times daily at 8 hour intervals (morning, afternoon, evening) over 6 consecutive days.
Drug: EUR-1025
orally, 8 mg, three times a day over 6 consecutive days
Other Name: Ondansetron
Experimental: Regime 4
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.
Drug: EUR-1025
orally, 8 mg, 16 mg, 24 mg, daily, for 6 days
Other Name: Ondansetron



Primary Outcome Measures :
  1. Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay. [ Time Frame: 6 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036854


Locations
Canada, Quebec
Algorithme Pharma INc.
Mount-Royal, Quebec, Canada, H3P 3PI
Sponsors and Collaborators
Forest Laboratories
Investigators
Principal Investigator: Eric Sicard, M.D. Algorithme Pharma Inc

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01036854     History of Changes
Other Study ID Numbers: ODO-P8-690
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by Forest Laboratories:
Ondansetron, EUR-1025

Additional relevant MeSH terms:
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents