NCT04854642

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

Influence of Food on the Oral Bioavailability of Ladarixin 200 mg Capsule in Healthy Volunteers of Both Sexes. A Single Dose (400 mg), Randomized, Open Label, Two-Way Crossover Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Single center, single dose, open label, randomized, two-way, crossover, food effect on bioavailability study. More precisely, a single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) and fasting (Reference treatment) conditions in two consecutive study periods, according to a two-way crossover design, with a wash-out interval of at least 14 days between the two administrations.

Conditions

• no Condition

Interventions

Type	Name	Description
DRUG	Ladarixin	A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) and fasting (Reference treatment) conditions in two consecutive study periods, according to a two-way crossover design, with a wash-out interval of at least 14 days between the two administrations.

Timeline

• Start date: 2020-10-20
• Primary completion: 2020-12-09
• Completion: 2020-12-09
• First posted: 2021-04-22
• Last updated: 2024-01-17
• Results posted: 2022-01-11

Locations

1 site across 1 country: Switzerland