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NCT06831344 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants
A Phase 1 study, sponsored by Phathom Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT06831344: Completed Phase 1 study, sponsored by Phathom Pharmaceuticals.
NCT06831344 is a Phase 1 study that has completed, run by Phathom Pharmaceuticals. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06831344, a Phase 1 study, has completed, sponsored by Phathom Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of two vonoprazan orally disintegrating tablet formulations (ODT-1 or ODT-2) administered without water or mixed with water and administered via a syringe relative to the vonoprazan tablet in healthy participants.
Primary Outcome
Cmax of Vonoprazan was reported.
Interventions
- DRUG Vonoprazan ODT-1 or ODT-2 without Water
- DRUG Vonoprazan ODT-1 or ODT-2 with Water
- DRUG Vonoprazan (Reference)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2025-04-10 |
| Phase | Phase 1 |
What the finished NCT06831344 record still lists
NCT06831344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Vonoprazan ODT-1 or ODT-2 without Water is the first listed.
NCT06831344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06831344 about?
NCT06831344 is a clinical study titled "A Study to Evaluate Two Vonoprazan Orally Disintegrating Tablet Formulations Administered Without Water or Mixed With Water and Administered Via a Syringe Relative to the Vonoprazan Tablet in Healthy Participants". The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of two vonoprazan orally disintegrating tablet formulations (ODT-1 or ODT-2) administered without water or mixed with water and administered via a syringe relative to the vonoprazan tablet in healthy part...
What is the current status of trial NCT06831344?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2025-02-14. Estimated completion is 2025-04-10.
What interventions are being tested in trial NCT06831344?
The interventions under investigation include: Vonoprazan ODT-1 or ODT-2 without Water (DRUG), Vonoprazan ODT-1 or ODT-2 with Water (DRUG), Vonoprazan (Reference) (DRUG).
Who is sponsoring clinical trial NCT06831344?
This trial is sponsored by Phathom Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06831344's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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