Single Dose Pharmacokinetics of Egalet® Hydrocodone

Study Overview
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Brief Summary
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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
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Outcomes: Pharmacokinetic parameters and bioequivalence testing.

Official Title
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A Single-Centre, Single Dose, Randomized,Open Label, Exploratory, 5-way Crossover Study Evaluating the Pharmakokinetic Profiles of Various Egalet® Hydrocodone Formulations In Healthy Volunteers Under Fasting Conditions.

Conditions
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Pain

Intervention / Treatment
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* Drug: hydrocodone
* Drug: hydrocodone & acetaminophen combination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egalet® hydrocodone treatment A<br>Single Dose administration | Drug: hydrocodone<br>* Extended Release tablet<br>|
| Experimental: Egalet® hydrocodone Treatment B<br>Single Dose Administration | Drug: hydrocodone<br>* Extended Release tablet<br>|
| Experimental: Egalet® hydrocodone Treatment C<br>Single Dose Administration | Drug: hydrocodone<br>* Extended Release tablet<br>|
| Experimental: Egalet® hydrocodone Treatment D<br>Single Dose Administration | Drug: hydrocodone<br>* Extended Release tablet<br>|
| Active Comparator: Active Comparator<br>Single Dose Administration | Drug: hydrocodone & acetaminophen combination<br>* Immediate Release tablet, hydrocodone and acetaminophen combination product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrocodone, Pharmacokinetics, Safety & Tolerability