At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
Vonoprazan +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-label, Randomized, Single-dose, Crossover Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating Vonoprazan for Healthy Volunteers. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedMay 2022
Enrollment StartMay 2022
Primary CompletionJul 2022
Study CompletionJul 2022
TodayJul 2026
First PostedMay 9, 2022
Enrollment StartMay 18, 2022
Primary CompletionJul 1, 2022
Study CompletionJul 26, 2022
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.1 years ago
Interventions
Vonoprazandrug
Orally via tablet
Vonoprazandrug
Orally via sprinkle pellets