A study comparing two inhalers in healthy volunteers (QBR117213)
Research type
Research Study
Full title
AN OPEN-LABEL, SINGLE-DOSE, RANDOMIZED, FIVE-PERIOD CROSSOVER STUDY TO COMPARE PHARMACOKINETIC PROFILES OF Z7200 AND SYMBICORT® TURBOHALER®, WITH AND WITHOUT CHARCOAL BLOCKADE, IN HEALTHY VOLUNTEERS.
IRAS ID
159640
Contact name
Clare Doherty
Contact email
Sponsor organisation
Zambon Spa
Eudract number
2014-002081-69
Clinicaltrials.gov Identifier
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 performs in the body compared to an already licenced product, Symbicort® Turbohaler® in man.
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 occasion.
REC name
HSC REC A
REC reference
14/NI/1044
Date of REC Opinion
6 Aug 2014
REC opinion
Further Information Favourable Opinion