drugset / Trial / NCT05627518

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

NCT05627518

Phase 1 Completed 67 enrolled Cinclus Pharma Holding AB
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2022-11-15
Primary completion
2022-12-30
Completion
2023-01-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Linaprazan Small molecule 100 mg Oral

Indications

No indication recorded.