At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Vonoprazan +1 moredrug
Likely dose
Vonoprazan 20 mgfrom 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.
An Open-Label, Fixed Sequence, Clinical Drug Interaction Study to Evaluate the Time-Dependent Inhibition Potential of Vonoprazan on a Sensitive CYP3A4 Substrate, Midazolam, in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Vonoprazan and Midazolam for Healthy Volunteers. Completed, enrolled 20 participants across 1 site.
Detailed Summary
To determine the time-dependent inhibition potential of repeated doses of oral vonoprazan on the pharmacokinetics (PK) of a single oral dose of midazolam, a sensitive cytochrome P450 3A4 (CYP3A4) substrate, in healthy participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartSep 2020
Primary CompletionNov 2020
Study CompletionNov 2020
TodayJul 2026
First PostedSep 11, 2020
Enrollment StartSep 15, 2020
Primary CompletionNov 13, 2020
Study CompletionNov 25, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.8 years ago
Interventions
Vonoprazandrug
20 mg tablets administered orally
Midazolamdrug
2 mg syrup administered orally