Single Dose Pharmacokinetics of Egalet® Hydrocodone

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: hydrocodone & acetaminophen combination; Drug: hydrocodone

• Registration Number: NCT00802087
• Lead Sponsor: Egalet Ltd

Brief Summary

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

Detailed Description

Outcomes:

Pharmacokinetic parameters and bioequivalence testing.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2008-12
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Study Completion: 2009-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Non-smokers
• ≥18 and ≤55 years of age
• BMI ≥19 and ≤30.0

Exclusion Criteria

• Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment
• History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening
• Allergic to hydrocodone, hydromorphone, other opioids, or related drugs
• Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration
• Pregnant or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Comparator	hydrocodone & acetaminophen combination	Single Dose Administration
Egalet® hydrocodone Treatment C	hydrocodone	Single Dose Administration
Egalet® hydrocodone Treatment D	hydrocodone	Single Dose Administration
Egalet® hydrocodone treatment A	hydrocodone	Single Dose administration
Egalet® hydrocodone Treatment B	hydrocodone	Single Dose Administration

Primary Outcome Measures

Name	Time	Method
To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24	Single-dose evaluation

Secondary Outcome Measures

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