Foster With or Without Charcoal Block or Aerochamber Plus

Launched by CHIESI FARMACEUTICI S.P.A. · Jan 19, 2011

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• 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.