A Single-center, Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of DWP14012 in Healthy Japanese, Caucasian and Korean
Abstract
To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects
Conditions: Healthy Volunteers.
Primary outcome: Cmax; Cmax,ss / Cmin,ss; Tmax; AUClast / AUCinf; T1/2; Percentage of total time that the intragastric pH was above 4; Percentage of total time that the intragastric pH was above 4.
Enrollment: 80 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: 80 participants or records.
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