NCT05627518

Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Cinclus Pharma Holding AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety
• Bioavailability
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Linaprazan glurate	100 mg

Timeline

• Start date: 2022-11-15
• Primary completion: 2022-12-30
• Completion: 2023-01-03
• First posted: 2022-11-25
• Last updated: 2025-04-03
• Results posted: 2025-04-03

Locations

1 site across 1 country: Slovenia