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

NCT01036854 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-02-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

EUR-1025

orally, 24 mg, daily for 6 days

DRUG

EUR-1025

orally, 8 mg, twice daily over 6 consecutive days

DRUG

EUR-1025

orally, 8 mg, three times a day over 6 consecutive days

DRUG

EUR-1025

orally, 8 mg, 16 mg, 24 mg, daily, for 6 days

Sponsors & Collaborators

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Eric Sicard, M.D. · Algorithme Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01036854 on ClinicalTrials.gov