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

Forest Laboratories

Status and phase: Completed; Phase 1

Conditions: Nausea

Treatments: Drug: EUR-1025

Study type: Interventional

Funder types: Industry

Identifiers

NCT01036854

ODO-P8-690

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 4 patient groups

Regime 1

Experimental group

Description:

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

Treatment:

Drug: EUR-1025

Drug: EUR-1025

Drug: EUR-1025

Drug: EUR-1025

Regime 2

Active Comparator group

Description:

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

Treatment:

Drug: EUR-1025

Drug: EUR-1025

Drug: EUR-1025

Drug: EUR-1025

Regime 3

Active Comparator group

Description:

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

Treatment:

Drug: EUR-1025

Drug: EUR-1025

Drug: EUR-1025

Drug: EUR-1025

Regime 4

Experimental group

Description:

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.

Treatment:

Drug: EUR-1025

Drug: EUR-1025

Drug: EUR-1025

Drug: EUR-1025