Trial | NCT01280175  Report issue

Title

Foster With or Without Charcoal Block or Aerochamber Plus
Pharmacokinetics and Lung Bioavailability of BDP/Formoterol HFA Fixed Combination After Single Administration in 12 Healthy Volunteers Using the Standard Actuator With or Without Charcoal Block or the Aerochamber Spacer.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    formoterol ...

  • Study Participants

    13
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
Study Started
Dec 31
2006
Primary Completion
Feb 28
2007
Study Completion
Feb 28
2007
Last Update
Aug 03
2020

Procedure charcoal block

Device Aerochamber Plus spacer

Drug pMDI standard actuator

pMDI + charcoal block Experimental

BDP/formoterol 100/6 µg pMDI with charcoal ingestion

pMDI + Aerochamber Plus Experimental

BDP/formoterol 100/6 µg with Aerochamber Plus

pMDI Active Comparator

BDP/formoterol 100/g µg pMDI

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.
No Results Posted