NCT02242734

Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment

Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate Extended-Release (HC-ER) 20mg Capsules

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules

Detailed description

Pharmacokinetics and relative bioavailability of hydrocodone and its metabolites under fasted conditions

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	20 mg HC-ER	1-72 hours
DRUG	20 mg HC-ER	1-72 hours
DRUG	20 mg HC-ER	1-72 hours

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2014-09-17
• Last updated: 2022-11-10