NCT02243241View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Healthy
Interventions
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.

Trial Locations (1)

78744

PPD Phase I Clinic, Austin

All Listed Sponsors
lead

Purdue Pharma LP

INDUSTRY

NCT02243241 - The Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets on QT /QTc Intervals in Healthy Adult Subjects | Biotech Hunter | Biotech Hunter