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

Trial Profile

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

Completed
Phase of Trial: Phase II

Latest Information Update: 22 Jul 2017

At a glance

  • Drugs Beclometasone/formoterol (Primary) ; Charcoal; Fluticasone propionate
  • Indications Asthma; Respiratory tract disorders
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Chiesi Farmaceutici SpA
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 01 Jan 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 29 Nov 2012 Planned End Date changed from 11 Jun 2013 to 1 Nov 2013 as reported by ClinicalTrials.gov.
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