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PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians

Asthma Clinical Trial

Official title:
A Single-center, Randomized, Double-blind, Single Dose, 4-way Cross-over, Placebo-controlled Ethnic Sensitivity Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, and Tolerability of Different Dosages of CHF 5993 Pressurized Metered Dose Inhaler (pMDI) in Caucasian and Japanese Healthy Subjects

Clinical Trial Summary

The purpose of conducting this study is to obtain PK data of Beclometasone Dipropionate (BDP)/Beclometasone-17-MonoPropionate (B17MP), Formoterol Fumarate (FF) and Glycopyrronium Bromide (GB) after inhalation of CHF 5993 in Japanese as well as Caucasian healthy subjects under the same setting.

Clinical Trial Description

The Study is single-centre, randomized, double-blind, single-dose, 4-way cross-over, placebo-controlled. The safety, tolerability, PD and PK of CHF 5993 will be assessed in Japanese and Caucasian healthy volunteers. A total of 32 healthy male and female volunteers are planned to be included where they will receive four different treatments (study drug or placebo) over four treatment periods. Standard safety assessments will be conducted during the study, including safety blood and urine laboratory tests, liver function tests, vital signs, physical examinations, ECGs, 24-hour Holter and observations of any adverse events. Blood samples will also be collected for PK analysis. Blood and urine samples will be collected for pharmacodynamics analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03859414
Study type Interventional
Source Chiesi Farmaceutici S.p.A.
Contact
Status Completed
Phase Phase 1
Start date March 18, 2019
Completion date July 24, 2019
View Details
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