A study comparing PK of two inhalers in healthy volunteers (QCL117639)
Research type
Research Study
Full title
AN OPEN-LABEL, RANDOMIZED, FIVE-PERIOD CROSSOVER, SINGLE-DOSE STUDY TO COMPARE PHARMACOKINETIC PROFILES OF Z7200 MEDIUM STRENGTH AND SYMBICORT® TURBOHALER®, WITH AND WITHOUT CHARCOAL BLOCKADE, IN HEALTHY VOLUNTEERS.
IRAS ID
189624
Contact name
Isabella Salerio
Contact email
Sponsor organisation
Zambon Spa
Eudract number
2015-003233-95
Duration of Study in the UK
0 years, 4 months, 28 days
Research summary
The Sponsor is developing the combination study drug, Z7200, for the potential treatment of asthma and COPD.
The study will compare the way that Z7200 medium strength is taken up by the body compared to an already licenced product, Symbicort® Turbohaler®.
The study will consist of 10 study sequences involving up to 90 healthy male and female subjects. Each subject will participate in 5 study periods and receive either Symbicort or Z7200 both with and without activated charcoal.
Due to high variability of the reference product a replicate dosing design will be employed such that each subject will be dosed with the Symbicort Turbohaler in the absence of charcoal on two occasions. A previous clinical study comparing Z7200 and Symbicort Turbohaler failed to show the products were comparable; part of the reason for this was assigned to the fact the Symbicort Turbohaler used was from a single batch. The high variability of Symbicort Turbohaler has been published therefore, for the current study, the Symbicort Turbohaler will be sourced from multiple batches in order to account for the high variability of the reference product.
REC name
Wales REC 2
REC reference
15/WA/0372
Date of REC Opinion
14 Dec 2015
REC opinion
Further Information Favourable Opinion