Single Dose Pharmacokinetics of Egalet® Hydrocodone

Phase 1CompletedNCT00802087

Egalet Ltd28 enrolled

Overview

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

Outcomes: Pharmacokinetic parameters and bioequivalence testing.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Pain

Interventions

hydrocodoneDRUG

Extended Release tablet

hydrocodone & acetaminophen combinationDRUG

Immediate Release tablet, hydrocodone and acetaminophen combination product

Eligibility

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

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Time frame: Single-dose evaluation

Secondary Outcomes

To evaluate safety and tolerability of Egalet® hydrocodone formulations. Hematology, biochemistry, urinalysis, ECG, vital signs (including pulse oximetry), and adverse events monitoring.

Time frame: Single-dose evaluation

Data from ClinicalTrials.gov

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