drugset / Trial / NCT04854642

A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers

NCT04854642

Phase 1 Completed 36 enrolled Dompé Farmaceutici S.p.A
RandomizedCrossoverOpen-labelTreatment

Summary

Primary objective: \- to investigate the effect of food on the bioavailability of DF 2156Y after single dose administration of 400 mg of ladarixin to healthy male and female volunteers under fed and fasting conditions. Secondary objectives: * to investigate the effect of gender on the bioavailability of DF 2156Y and its metabolites (DF 2108Y and DF 2227Y) after single dose administration of 400 mg of ladarixin to healthy male and female volunteers * to evaluate safety and tolerability of a single dose administration of ladarixin 400 mg to healthy male and female volunteers.

Timeline

Start
2020-10-20
Primary completion
2020-12-09
Completion
2020-12-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ladarixin Unknown 400 mg Oral

Indications

No indication recorded.