A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants

Summary

The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of vonoprazan 20 mg sprinkle capsule, either sprinkled on pudding or on applesauce, relative to a vonoprazan 20 mg tablet in healthy participants.

Timeline

Start

2022-05-18

Primary completion

2022-07-01

Completion

2022-07-26

Outcome

Met primary endpoint

registry analysis (equivalence test); Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding vs Treatment C: Vonoprazan 20 mg Tablet; Ratio of Geometric Least Square Means 103.36 (90% CI 97.64 to 109.41) NCT05366738 ↗

registry analysis (equivalence test); Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce vs Treatment C: Vonoprazan 20 mg Tablet; Ratio of Geometric Least Square Means 97.83 (90% CI 92.42 to 103.56) NCT05366738 ↗

registry analysis (equivalence test); Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding vs Treatment C: Vonoprazan 20 mg Tablet; Ratio of Geometric Least Square Means 102.56 (90% CI 97.25 to 108.15) NCT05366738 ↗

registry analysis (equivalence test); Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce vs Treatment C: Vonoprazan 20 mg Tablet; Ratio of Geometric Least Square Means 97.61 (90% CI 92.55 to 102.93) NCT05366738 ↗

registry analysis (equivalence test); Treatment A: Vonoprazan 20 mg Sprinkle Capsule on Pudding vs Treatment C: Vonoprazan 20 mg Tablet; Ratio of Geometric Least Square Means 103.96 (90% CI 96.49 to 112.00) NCT05366738 ↗

registry analysis (equivalence test); Treatment B: Vonoprazan 20 mg Sprinkle Capsule on Applesauce vs Treatment C: Vonoprazan 20 mg Tablet; Ratio of Geometric Least Square Means 100.60 (90% CI 93.38 to 108.39) NCT05366738 ↗

Drugs

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

Indications

No indication recorded.