NCT02243241

The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects

A Randomized, Double-blind, Placebo- and Positive-Controlled, Parallel Group, Dose Escalating Study of the Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets at Doses up to 160 mg on QT/QTc in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg tablets) on the QT/QTc interval.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HYD	Hydrocodone bitartrate 80 mg (day 9), 120 mg (day 12), 160 mg \[(1) 40 mg tablet + (1) 120 mg tablet\] (day 15) extended-release tablets administered orally every 24 hours.
DRUG	Moxifloxacin	Moxifloxacin 400 mg tablets administered orally on the morning of day 9, day 12, and day 15 only.
DRUG	Placebo for HYD	Placebo to match HYD tablets administered orally every 24 hours.
DRUG	Placebo for moxifloxacin	Placebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only.

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2014-09-17
• Last updated: 2014-09-17

Locations

1 site across 1 country: United States