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.

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.

Conditions

• Asthma

Interventions

DRUG

Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend)

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

DRUG

Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend)

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

DRUG

Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend)

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

DRUG

Salbutamol Sulphate 200mcg UD-DPI Blister(1% blend)

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

DRUG

Salbutamol Diskus 200mcg Blister

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

DRUG

Salbutamol MDI 100mcg

Salbutamol MDI 100mcg will be supplied as formulation of salbutamol sulphate (micronized) in propellant contained within the pressurised MDI device

DRUG

Salbutamol Sulphate UD-DPI Blister (selected from Part A)

Formulation will be determined depending on the outcome of Part A.

DRUG

Salbutamol Sulphate 250mcg UD-DPI Blister (selected from Part A)

Formulation will be determined depending on the outcome of Part A.

DRUG

Salbutamol Diskus 200mcg Blister without activated charcoal

Formulation will be determined depending on the outcome of Part A.

DRUG

Salbutamol Diskus 200mcg Blister with activated charcoal

Formulation will be determined depending on the outcome of Part A.

DRUG

Salbutamol MDI 100mcg without activated charcoal

Formulation will be determined depending on the outcome of Part A.

DRUG

Salbutamol MDI 100mcg with activated charcoal

Formulation will be determined depending on the outcome of Part A.

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-10-21

Primary Completion

2014-05-26

Completion

2014-05-26

Countries

• Australia

Study Locations