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

NCT02243241 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2014-09-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02243241 on ClinicalTrials.gov