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

NCT01036854 | Completed Phase 1

• 1 other identifier: ODO-P8-690
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea

Keywords

Ondansetron, EUR-1025

Outcome Measures

Primary Outcomes (1)

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

  6 days

Study Arms (4)

Regime 1

EXPERIMENTAL

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

Drug: EUR-1025

Regime 2

ACTIVE COMPARATOR

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

Drug: EUR-1025

Regime 3

ACTIVE COMPARATOR

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

Drug: EUR-1025

Regime 4

EXPERIMENTAL

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

Interventions

EUR-1025 DRUG

orally, 24 mg, daily for 6 days

Also known as: Ondansetron

Regime 1

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (1)

Algorithme Pharma INc.

Mount Royal, Quebec, H3P 3PI, Canada

Location

MeSH Terms

Conditions

Nausea

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Eric Sicard, M.D.

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

CA (1)