NCT02237508View on ClinicalTrials.gov

A Clinical Study to Evaluate Z7200 (Budesonide/Formoterol) Pharmacokinetics Profile in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Asthma
Interventions
DRUG

Z7200 without oral activated charcoal

160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler (Treatment A).

DRUG

Symbicort Turbohaler without oral activated charcoal

320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation (Treatments B1 and B2).

DRUG

Z7200 with oral activated charcoal

160 ug budesonide and 4.5 ug formoterol fumarate dihydrate, administered as two inhalations (2 x Z7200 capsules) of budesonide 80 ug/inhalation and formoterol 2.25 ug/inhalation, using an RS01 inhaler with a charcoal blockade (Treatment C).

DRUG

Symbicort Turbohaler with oral activated charcoal

320 ug budesonide and 9 ug formoterol fumarate dihydrate, administered as two inhalations of budesonide 160 ug/inhalation and formoterol 4.5 ug/inhalation from a Symbicort Turbohaler, with charcoal blockade (Treatment D).

Trial Locations (1)

NG11 6JS

Quotient Clinical Ltd, Ruddington

All Listed Sponsors
lead

Zambon SpA

INDUSTRY

NCT02237508 - A Clinical Study to Evaluate Z7200 (Budesonide/Formoterol) Pharmacokinetics Profile in Healthy Volunteers | Biotech Hunter | Biotech Hunter