Single Dose Pharmacokinetics of Egalet® Hydrocodone

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00802087

Enrollment

Registered

2008-12-04

Start date

2008-11-30

Completion date

2009-04-30

Last updated

2016-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Hydrocodone, Pharmacokinetics, Safety & Tolerability

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.

Interventions

DRUGhydrocodone

Extended Release tablet

DRUGhydrocodone & acetaminophen combination

Immediate Release tablet, hydrocodone and acetaminophen combination product

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026