Single Dose Pharmacokinetics of Egalet® Hydrocodone

Egalet

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: hydrocodone; Drug: hydrocodone & acetaminophen combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT00802087

HC-EG-001

Details and patient eligibility

About

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

Full description

Outcomes:

Pharmacokinetic parameters and bioequivalence testing.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 5 patient groups

Egalet® hydrocodone treatment A

Experimental group

Description:

Single Dose administration

Treatment:

Drug: hydrocodone

Egalet® hydrocodone Treatment B

Experimental group

Description:

Single Dose Administration

Treatment:

Drug: hydrocodone

Egalet® hydrocodone Treatment C

Experimental group

Description:

Single Dose Administration

Treatment:

Drug: hydrocodone

Egalet® hydrocodone Treatment D

Experimental group

Description:

Single Dose Administration

Treatment:

Drug: hydrocodone

Active Comparator

Active Comparator group

Description:

Single Dose Administration

Treatment:

Drug: hydrocodone & acetaminophen combination