NCT02117141

To Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release Capsules

A Pilot Study in Healthy Volunteers to Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release (HC-ER) Capsules, in Both Fed and Fasted States

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Zogenix, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

* Assess the rate and extent of absorption of hydrocodone from a 20 mg HC-ER capsule in both fed and fasted states * Evaluate the safety and tolerability of the test compound administered orally

Detailed description

Safety parameters assessed included medical history, physical examination, vital signs, 12-lead ECGs, clinical laboratory testing and adverse event assessment.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HC-ER 20 mg capsule (fasted)	Single oral dose HC-ER 20 mg capsule after overnight fast (fasted)
DRUG	HC-ER 20 mg capsule (fed)	Single oral dose HC-ER 20 mg capsule after high fat meal (fed)

Timeline

• Start date: 2002-06-01
• Primary completion: 2002-06-01
• Completion: 2002-06-01
• First posted: 2014-04-17
• Last updated: 2022-11-10