MedTrace Logo

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

NCT06831344 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-19

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Vonoprazan ODT-1 or ODT-2 without Water

Vonoprazan will be administered orally as an ODT-1 or ODT-2 without water

DRUG

Vonoprazan ODT-1 or ODT-2 with Water

Vonoprazan will be administered orally as an ODT-1 or ODT-2 with water via a syringe

DRUG

Vonoprazan (Reference)

Vonoprazan will be administered orally as a tablet

Sponsors & Collaborators

  • Phathom Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Phathom Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-14
Primary Completion
2025-04-05
Completion
2025-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06831344 on ClinicalTrials.gov