CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
Vonoprazan +2 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.

Search/NCT02037477
NCT02037477Phase 3Completed
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Phase 3 Open-Label Crossover Pharmacodynamic Study to Evaluate the Acid-inhibitory Effect of TAK-438 20 mg With Esomeprazole 20 mg or Rabeprazole Sodium 10 mg in Healthy Adult Male Subjects

Takeda·interventional·Posted Jan 16, 2014·Updated Oct 17, 2016

In Brief

A Phase 3 clinical trial evaluating Vonoprazan, Esomeprazole, and 1 other intervention for Healthy Volunteers. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the acid-inhibitory effect of multiple oral doses of Vonoprazan (TAK-438) and the relative effect of vonoprazan versus two controls (esomeprazole and rabeprazole sodium) in healthy Japanese adult male participants with the CYP2C19 extensive metabolizer (EM) genotype.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 16, 2014
Enrollment StartJan 1, 2014
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.5 years ago

Interventions

Vonoprazandrug

Vonoprazan tablets

Esomeprazoledrug

Esomeprazole capsules

Rabeprazole sodiumdrug

Rabeprazole sodium tablets