GSK Investigational Site
Randwick, New South Wales, 2031, Australia
NCT Number: NCT01984086
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Randwick, New South Wales, 2031, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part B
Exclusion criteria
Part B
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.
Time frame: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)
PK parameters include: area under the concentration-time curve from time zero (pre-dose) to 12 hours (hr) (AUC [0-12hr]) and/ or area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC [0-infinity]) and/ or area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC [0-t]) and maximum observed concentration (Cmax).
Time frame: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)
PK parameters include: AUC(0- infinity) or AUC(0-t) and Cmax
Time frame: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)
PK parameters include: area under the concentration-time curve from time zero (pre-dose) to 30 min (AUC [0-30 min]) and time to maximum observed concentration (tmax).
Time frame: Day 1 of each treatment period (Pre dose and 0 hr, 2 minute [min], 5 min, 10 min, 20 min, 30 min, 45 min, 1hr, 1.5 hr, 2hr, 4 hr, 6 hr, 8 hr, 10 hr and 12 hr post dose)
PK parameters include: AUC [0 30 min] and tmax
Time frame: Up to 14 days after the last dose of study treatment.
Time frame: Day 1 of each treatment period
Vital sign measurements to be measurement include systolic and diastolic blood pressure and pulse rate
Time frame: Day 1 of each treatment period
Single 12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT interval using Fredericia's formula (QTcF) intervals.
GlaxoSmithKline
Industry
An Open-label, Randomised, Cross-over, Two Cohort, Single Dose Study in Healthy Volunteers to Evaluate the Unit Dose Dry Powder Inhaler (UD-DPI) for the Delivery of Salbutamol and to Compare the Pharmacokinetic Profile With the MDI and Diskus Presentations.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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