CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 67 enrolled
Drug / intervention
Linaprazan gluratedrug
Likely dose
Linaprazan glurate 100 mgfrom 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/NCT05627518
NCT05627518Phase 1Completed

A Randomized, Single Dose, Crossover Study in Healthy Volunteers to Investigate the Relative Bioavailability of Linaprazan for a New Oral Tablet Formulation of Linaprazan Glurate, and to Assess the Effect of Food on the Pharmacokinetics of Linaprazan

Cinclus Pharma Holding AB·interventional·Posted Nov 25, 2022·Updated Apr 3, 2025

In Brief

A Phase 1 clinical trial evaluating Linaprazan glurate for Safety and 2 related conditions. Completed, enrolled 67 participants across 1 site.

Detailed Summary

This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSlovenia
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedNov 25, 2022
Enrollment StartNov 15, 2022
Primary CompletionDec 30, 2022
Study CompletionJan 3, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.6 years ago

Interventions

Linaprazan gluratedrug

100 mg