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A Study to Determine the Bioavailability of Vonoprazan Sprinkle Capsules on Pudding or on Applesauce Relative to a Vonoprazan Tablet in Healthy Participants

NCT05366738 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-03-29

Study results available
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Summary

The primary objective of this study is to assess the bioavailability (BA) of a single oral dose of vonoprazan 20 mg sprinkle capsule, either sprinkled on pudding or on applesauce, relative to a vonoprazan 20 mg tablet in healthy participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Vonoprazan

Orally via tablet

DRUG

Vonoprazan

Orally via sprinkle pellets

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
2022-05-18
Primary Completion
2022-07-01
Completion
2022-07-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05366738 on ClinicalTrials.gov