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

This study has been completed.
Information provided by:
Aptalis Pharma Identifier:
First received: December 17, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

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 Intervention Phase
Drug: EUR-1025
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by Aptalis Pharma:

Primary Outcome Measures:
  • Ondansetron plasma concentrations will be measured by using a validated HPLC/MS assay. [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Enrollment: 128
Study Start Date: February 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regime 1
Regime 1 will be orally administered once daily in the morning over 6 consecutive days.
Drug: EUR-1025
oral, 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 ove r6 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

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.


Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01036854

Canada, Quebec
Algorithme Pharma INc.
Mount-Royal, Quebec, Canada, H3P 3PI
Sponsors and Collaborators
Aptalis Pharma
Principal Investigator: Eric Sicard, M.D. Algorithme Pharma Inc
  More Information

No publications provided

Responsible Party: Ruth Thieroff-Ekerdt, M.D., Eurand Pharmaceuticals, Inc. Identifier: NCT01036854     History of Changes
Other Study ID Numbers: ODO-P8-690
Study First Received: December 17, 2009
Last Updated: December 17, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Aptalis Pharma:
Ondansetron, EUR-1025

Additional relevant MeSH terms:
Anti-Anxiety Agents
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents processed this record on November 25, 2014