The purpose of this study is to assess the effects of domperidone on the QTc interval duration in Chinese healthy adult participants after multiple domperidone doses of 10 milligram (mg) 3 times a day (tid) and 20 mg tid.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
Domperidone 10 mg or 20 mg tablets will be administered.
Matching placebo will be administered.
Moxifloxacin 400 mg tablet will be administered.
Unnamed facility
Beijing, China
Change From Baseline in QTc Interval Based on Fridericia Correction Method (QTcF)
The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).
Time frame: Baseline, Day 1 and Day 4
Change From Baseline in QTc Interval Based on Study-Specific Power Correction (QTcP)
The QT interval corrected for heart rate (QTc interval) using study-specific power correction method will be measured by electrocardiograms (ECG).
Time frame: Baseline, Day 1 and Day 4
Change From Baseline in QTc Interval Based on Bazett Method (QTcB)
The QT interval corrected for heart rate (QTc interval) using Bazett method will be measured by electrocardiograms (ECG).
Time frame: Baseline, Day 1 and Day 4
Change From Baseline in HR, QRS and PR Intervals
The HR, QRS, and PR Intervals will be measured by ECG.
Time frame: Baseline, Day 4
Maximum Observed Plasma Concentration
The Cmax is the maximum observed plasma concentration.
Time frame: Day 1
Time to Reach the Maximum Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time frame: Day 1 and Day 4 (Predose up to 5 hours post dose)
Area Under the Plasma Concentration-Time Curve During the First Dosing Interval (AUCtau)
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
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Time frame: Day 1 and Day 4 (Predose up to 5 hours post dose)
Maximum Plasma Concentration at Steady State (Cmax,ss)
The Cmax,ss is the maximum observed plasma concentration at steady state.
Time frame: Day 4 (Predose up to 5 hours post dose)
Minimum Plasma Concentration at Steady State (Cmin,ss)
The Cmin,ss is the minimum observed plasma concentration at steady state.
Time frame: Day 4 (Predose up to 5 hours post dose)
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) as a Measure of Safety and Tolerability
Time frame: Up to End of Study (4 to 10 days after last study drug administration)