A Phase I Pharmacokinetic Study of Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 Microgram [mcg]) After Single and Repeat Dose Administration From a Dry Powder Inhaler in Healthy Chinese Subjects

Summary

This is an open-label study to evaluate the PK of FF/UMEC/VI in dose combinations of 100/62.5/25 mcg after single and repeat dose administration from a DPI in healthy Chinese subjects. This study will evaluate the systemic pharmacokinetics (PK), of FF/UMEC/VI in Chinese healthy population when administered using dry powder inhaler (DPI)as a blended combination of UMEC/VI in one strip and FF in the second strip in dose combinations of 100/62.5/25 mcg. The triple, fixed dose combination product Fluticasone furoate(FF)/ Vilanterol (VI) /Umeclidinium bromide (UMEC) with new configuration enables the delivery of inhaled long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA) and inhaled corticosteroid (ICS) from a single device. Approximately 16 subjects will be enrolled in the study. After taking into account the allowable time windows for screening, treatment and follow-up, a subject will be in the study for a maximum duration of 6-7 weeks.

Timeline

Start

2016-09

Primary completion

2016-11

Completion

2016-11

Publications

• Li Y, Li H, Sheng Y, Du X, Yao Y, Luo X, Ma P. Pharmacokinetics of Single and Repeat Doses of Fluticasone Furoate/Umeclidinium/Vilanterol in Healthy Chinese Adults. Clin Pharmacol Drug Dev. 2019 Aug;8(6):721-733. doi: 10.1002/cpdd.626. Epub 2018 Nov 14.

Drugs

Indications