Conditions: Safety Bioavailability Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 67
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: 100 mg linaprazan glurate reference formulation (4x25 mg oral tablets) in fasting conditions arm 2: 100 mg linaprazan glurate test formulation (1x100 mg oral tablet) in fasting conditions arm 3: 100 mg linaprazan glurate test formulation (1x100 mg oral tablet) in fed conditions

Interventions: intervention 1: Linaprazan glurate
Intervention descriptions: intervention 1: 100 mg

Protocol document:
Prot_000.pdf: 















































































































































SAP_001.pdf: