NCT01984086View on ClinicalTrials.gov

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.

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 21, 2013

Primary Completion Date

May 26, 2014

Study Completion Date

May 26, 2014

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.

Trial Locations (1)

2031

GSK Investigational Site, Randwick

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY