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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
208
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.
Moxifloxacin 400 mg tablets administered orally on the morning of day 9, day 12, and day 15 only.
Placebo to match HYD tablets administered orally every 24 hours.
PPD Phase I Clinic
Austin, Texas, United States
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
The electrocardiogram (ECG) effects of HYD 80 mg (day 9) on the QT/QTc interval
Time frame: Baseline and Day 9
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
The ECG effects of HYD 120 mg (day 12) on the QT/QTc interval
Time frame: Baseline and Day 12
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
The ECG effects of HYD 160 mg (day 15) on the QT/QTc interval
Time frame: Baseline and Day 15
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
The ECG effects of moxifloxacin (day 9) on the QT/QTc interval
Time frame: Baseline and Day 9
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
The ECG effects of moxifloxacin (day 12) on the QT/QTc interval
Time frame: Baseline and Day 12
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
The ECG effects of moxifloxacin (day 15) on the QT/QTc interval
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Placebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only.
Time frame: Baseline and Day 15