A Randomized, Open-label, Multiple Dose, Two-part Phase I Clinical Trial to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of DWP14012 After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxicillin in Healthy Male Subjects
Abstract
This is a randomized, open-label, multiple dose, two-part phase I clinical trial to compare the pharmacokinetics, pharmacodynamics and safety/tolerability of DWP14012 after administrations of DWP14012 alone and combinations of DWP14012, Clarithromycin and Amoxicillin in healthy male subjects
Conditions: Healthy.
Primary outcome: Cmax,ss: Maximum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state; Cmin,ss: Minimum concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state; Cav,ss: Average concentration of DWP14012, clarithromycin and metabolite and amoxicillin at steady state; AUCt,ss: Area under the drug concentration-time curve within a dosing interval at steady states; Tmax,ss: Time of maximum concentration at steady state; T1/2: Elimination half-life; Percentage of total time that the intragastric pH was above 4; Percentage of total time that the intragastric pH was above 4; Percentage of total time that the intragastric pH was above 6; Percentage of total time that the intragastric pH was above 6; Serum gastrin concentration profile; Serum gastrin concentration profile; Number of participants with Adverse Events (AE); Number of Participants With Clinically Significant Vital Sign findings; Number of Participants With Clinically Significant Electrocardiogram(12-lead ECG) findings; Number of Participants With Clinically Significant Laboratory results.
Enrollment: 48 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 48 participants or records.
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