Healthy Volunteers
Conditions
Keywords
BDP, Formoterol, pMDI, Aerochamber Plus, Charcoal
Brief summary
The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the standard actuator
Interventions
Sponsors
Cross Research S.A.
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Sex: male * 18≤age≤45 years old * BMI: 18≤BMI≤28 kg/m2 * Non-smokers * Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm, measured after 5 min of rest in the sitting position * Full comprehension: ability to use correctly the pMDI preparations; ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study * Informed Consent: signed written informed consent prior to inclusion in the study.
Exclusion criteria
* ECG (12 leads): clinically relevant abnormalities and/or QTc \>450 msec; * Physical findings: clinically relevant abnormal physical findings, which could interfere with the objectives of the study; in particular any abnormality in the lung functionality: FEV1 \<80% predicted values according to European Respiratory Society basing upon Quanjer et al. (25) * Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness; in particular positive HIV1 and HIV2 serology and/or positive hepatitis serology indicating acute or chronic hepatitis B or C * Allergy: ascertained or presumptive hypersensitivity to the active principles and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study * Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study * Medications: medication, including OTC, during 2 weeks before the start of the study. Any known enzyme inducing drug or enzyme inhibitor must be stopped at least 2 months before study start * Investigative drug trials: participation in the evaluation of any drug within 3 months prior to the screening * Blood donation: blood donations during the 3 months prior to this study * Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[\>2 drinks/day, defined according to USDA Dietary Guidelines 2005 (26)\], caffeine (\>5 cups coffee/tea/day) abuse or smoking * Abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic exposure and lung bioavailability of BDP, B17MP and formoterol. | from pre-dose until 12 h post-dose |
Secondary
| Measure | Time frame |
|---|---|
| General tolerability and safety of the test product. | from pre-dose until 12 h post-dose |
Countries
Switzerland
Outcome results
None listed