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

This study has been completed.
Sponsor:
Information provided by:
Aptalis Pharma
ClinicalTrials.gov Identifier:
NCT01036854
First received: December 17, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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
Nausea
 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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01036854

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

No publications provided

Responsible Party: Ruth Thieroff-Ekerdt, M.D., Eurand Pharmaceuticals, Inc.
ClinicalTrials.gov 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:
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 23, 2013