Single Dose Pharmacokinetics of Egalet® Oxycodone

Egalet Ltd16 enrolled

Overview

The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® oxycodone formulations and compare to a marketed oxycodone product.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Pain

Interventions

Oxycodone hydrochlorideDRUG

Extended release tablet

Oxycodone hydrochlorideDRUG

Extended release tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main inclusion criteria: * ≥18 years and ≤55 years * Non-smoker * BMI ≥18.0 and ≤30.0 Main exclusion criteria: * Any clinically significant abnormality or abnormal laboratory test results found during medical screening * History of allergic reactions to opioids or other related drugs * History of significant alcohol abuse or drug abuse * Use of any drugs known to inhibit hepatic drug metabolism * Pregnant or breast-feeding

Locations (1)

Unnamed facility

Québec, Quebec, Canada

Outcomes

Primary Outcomes

To evaluate pharmacokinetics of Egalet® oxycodone. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el,Kel,AUC 0-12 and AUC 0-24.

Time frame: Single-dose evaluation

Secondary Outcomes

To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring.

Time frame: Single-dose evaluation

Data from ClinicalTrials.gov

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