A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan (20 mg) and Lansoprazole (30 mg) in Healthy Subjects
Abstract
To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of vonoprazan (20 mg) and lansoprazole (30 mg) following single (Day 1) and multiple doses (Day 7).
Conditions: Healthy Participants.
Primary outcome: Gastric pH >4 Holding Time Ratio (HTR): Percentage of Time Gastric pH Was Above 4 Over a 24-hour Monitoring Period Following Study Drug Administration; Mean Gastric pH Over a 24-hour Monitoring Period Following Study Drug Administration (pH0-24); Area Under the Concentration-Time Curve From Time 0 to the 24-Hour Time Point (AUC0-24); Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf); Maximum Observed Plasma Concentration (Cmax); Time to Reach Cmax (Tmax); Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) at Steady State (ss); Cmax at Steady State (Cmax,ss); Tmax at Steady State (Tmax,ss).
Enrollment: 44 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: 44 participants or records.
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