Single Dose Pharmacokinetics of Egalet® Hydrocodone

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Egalet Ltd
• Treatments: Acetaminophen; Hydrocodone

Criteria

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