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A PHASE II, MONOCENTRE, OPEN, RANDOMIZED, 6-WAY CROSS-OVER CLINICAL PHARMACOLOGY STUDY TO EVALUATE THE LUNG BIOAVAILABILITY OF BDP/B17MP AND FORMOTEROL AND THE TOTAL SYSTEMIC EXPOSURE ACROSS TWO DIFF...

Mise à jour : Il y a 4 ans
Référence : EUCTR2012-002370-30

A PHASE II, MONOCENTRE, OPEN, RANDOMIZED, 6-WAY CROSS-OVER CLINICAL PHARMACOLOGY STUDY TO EVALUATE THE LUNG BIOAVAILABILITY OF BDP/B17MP AND FORMOTEROL AND THE TOTAL SYSTEMIC EXPOSURE ACROSS TWO DIFFERENT DOSE STRENGTHS OF CHF 1535 NEXThaler® DPI (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE 100/6 µg and 200/6 µg) ADMINISTERED WITH AND WITHOUT ACTIVATED CHARCOAL IN ADULT ASTHMATIC PATIENTS

Femme et Homme

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Extrait

• To evaluate the lung bioavailability of B17MP (active metabolite of BDP) and formoterol as AUC0-t across two different dose strengths of CHF 1535 NEXThaler DPI (100/6 µg, 200/6 µg) with activated charcoal. • To evaluate the total systemic exposure to B17MP (active metabolite of BDP) and to Formoterol as AUC0-t across two different dose strengths of CHF 1535 NEXThaler DPI (100/6 µg, 200/6 µg) without activated charcoal.

Critère d'inclusion

  • Asthma

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