Phase I study to compare PK of tiotropium products (QSC200665)
Research type
Research Study
Full title
Open label, randomised two-period cross-over study in healthy male and non-pregnant female volunteers to compare the single-dose pharmacokinetics of tiotropium delivered from a test pMDI product with Spiriva® Respimat®
IRAS ID
245871
Contact name
Lester Harrison
Contact email
Sponsor organisation
Kindeva Drug Delivery L.P. (formerly 3M Drug Delivery Systems)
Eudract number
2018-003919-22
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
The Sponsor is developing a test product that delivers tiotropium via inhalation methods to be equivalent to that of a commercial reference product (Spiriva® Respimat®). The test product is for the potential treatment of chronic obstructive pulmonary disease (COPD) and asthma. The treatment investigated in this study could treat the narrowing of the airways associated with the diseases.\n\nThe primary aim of this study is to compare the rates and extent of absorption of the test and reference inhalation products into the blood. The secondary aims are to determine the time to maximum absorption into the blood and side effects of the test and reference inhalation products.\n\nThe study is a randomised two-period cross-over study where up to 102 healthy male and female (non-pregnant) volunteers will receive two inhalations as a single dose of tiotropium from the test and the reference product (one product for each treatment period). Volunteers will receive the same dose of reference product as recommended for patients with COPD or asthma. The amount of tiotropium absorbed from the test product is expected to be about the same as from the reference product. Doses will be separated by 19 to 28 days. Following each administration, blood samples will be taken for 72 hours.\n
REC name
Wales REC 2
REC reference
18/WA/0393
Date of REC Opinion
15 Nov 2018
REC opinion
Favourable Opinion