Study to Evaluate the Pharmacokinetic Profile of Salbutamol Delivered by Unit Dose Dry Powder Inhaler (UD-DPI) Compared to the Diskus and Metered Dose Inhaler (MDI) in Healthy Volunteers.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, two part, six period- cross over, randomised, single dose, single
      centre study in healthy subjects. This is the first clinical study for the UD-DPI. This study
      is divided into two parts. Part A will ascertain whether the pharmacokinetic (PK) of
      salbutamol delivered via the UD-DPI is comparable to the salbutamol delivered via the Diskus
      or MDI. For this reason four treatment doses consisting of three dose strength and two
      percentage blends will be assessed in Part A delivered via UD-DPI. Part A will also provide
      preliminary PK variability estimates to allow for better sample size/precision calculations
      for Part B. Part B will explore whether the UD-DPI has a pharmacokinetic exposure profile
      that is comparable to either Diskus or MDI in the presence of the charcoal block.
    


Intervention name(s): Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend); Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend); Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend); Salbutamol Sulphate 200mcg UD-DPI Blister(1% blend); Salbutamol Diskus 200mcg Blister; Salbutamol MDI 100mcg; Salbutamol Sulphate UD-DPI Blister (selected from Part A); Salbutamol Sulphate 250mcg UD-DPI Blister (selected from Part A); Salbutamol Diskus 200mcg Blister without activated charcoal; Salbutamol Diskus 200mcg Blister with activated charcoal; Salbutamol MDI 100mcg without activated charcoal; Salbutamol MDI 100mcg with activated charcoal
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Salbutamol Sulphate 150mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients; Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients; Salbutamol Sulphate 250mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients; Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients; Salbutamol Diskus 200mcg will be supplied as blister strip contained within the Diskus device. Each blister contains a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients; Salbutamol MDI 100mcg will be supplied as formulation of salbutamol sulphate (micronized) in propellant contained within the pressurised MDI device; Formulation will be determined depending on the outcome of Part A.; Formulation will be determined depending on the outcome of Part A.; Formulation will be determined depending on the outcome of Part A.; Formulation will be determined depending on the outcome of Part A.; Formulation will be determined depending on the outcome of Part A.; Formulation will be determined depending on the outcome of Part A.
Intervention MeSH terms: Albuterol; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Asthma; Respiratory