Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan and Lansoprazole in Healthy Participants

Summary

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).

Timeline

Start

2021-01-28

Primary completion

2021-06-12

Completion

2021-06-26

Outcome

Met primary endpoint

registry analysis (other test); Vonoprazan vs Lansoprazole; Least-squares mean difference 38.98 (95% CI 31.94 to 46.02) NCT04729101 ↗

registry analysis (other test); Vonoprazan vs Lansoprazole; Least-squares mean difference 44.62 (95% CI 37.55 to 51.69) NCT04729101 ↗

registry analysis (other test); Vonoprazan vs Lansoprazole; Least-squares mean difference 1.72 (95% CI 1.40 to 2.04) NCT04729101 ↗

registry analysis (other test); Vonoprazan vs Lansoprazole; Least-squares mean difference 2.09 (95% CI 1.74 to 2.44) NCT04729101 ↗

Publications

• Laine L, Sharma P, Mulford DJ, Hunt B, Leifke E, Smith N, Howden CW. Pharmacodynamics and Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan and the Proton Pump Inhibitor Lansoprazole in US Subjects. Am J Gastroenterol. 2022 Jul 1;117(7):1158-1161. doi: 10.14309/ajg.0000000000001735. Epub 2022 Mar 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lansoprazole	Other / unclassified	30 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral

Indications

No indication recorded.