Single Dose Pharmacokinetics of Egalet® Oxycodone

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Oxycodone hydrochloride

• Registration Number: NCT00801788
• Lead Sponsor: Egalet Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2008-10
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Study Completion: 2009-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Egalet® oxycodone Treatment A	Oxycodone hydrochloride	Single Dose Administration
Egalet® oxycodone Treatment B	Oxycodone hydrochloride	Single Dose Administration
Egalet® oxycodone Treatment C	Oxycodone hydrochloride	Single Dose Administration
Active comparator	Oxycodone hydrochloride	Single Dose Administration

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of Egalet® oxycodone. Hematology, biochemistry, urinalysis, vital signs (including pulse oximetry), and adverse event monitoring.	Single-dose evaluation