At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
Vonoprazandrug
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 Study to Evaluate Vonoprazan Concentrations in Breast Milk of Healthy Lactating Women Receiving Vonoprazan 20 mg Once Daily or Vonoprazan 20 mg Twice Daily
In Brief
A Phase 1 clinical trial evaluating Vonoprazan for Erosive Esophagitis and 3 related conditions. Completed, enrolled 15 participants across 1 site.
Detailed Summary
The primary objective is to determine the pharmacokinetics (PK) of vonoprazan in breast milk of healthy lactating women who have received vonoprazan administered once daily or vonoprazan 20 mg administered twice daily for 4 consecutive days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErosive Esophagitis, Heartburn, Symptomatic Nonerosive Gasroesophageal Reflux Disease, Helicobacter Pylori Infection
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20252026
First PostedApr 2024
Enrollment StartMay 2024
Primary CompletionSep 2024
Study CompletionSep 2024
TodayJul 2026
First PostedApr 30, 2024
Enrollment StartMay 7, 2024
Primary CompletionSep 13, 2024
Study CompletionSep 19, 2024
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.2 years ago
Interventions
Vonoprazandrug
Oral tablet.