Asthma
Conditions
Interventions
A study treatment will be given on Day 1, and Day 4. Each time the volunteer
will receive a dose of 800 microgram of salbutamol. This will be given by
inhaling 8 puffs of 100 microgram each with 20
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Sex: male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal 2. Age : 18 to 50 years, inclusive, at screening 3. BMI : 18.0 to 30.0 kg/m2, inclusive, at screening 4. Weight : >=50 kg 5. Status : healthy participants Further criteria apply
Exclusion criteria
Exclusion criteria: 1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. 2. History or presence of any form of asthma, including childhood asthma and exercise induced asthma. 3. Systolic blood pressure 140 mmHg, or diastolic blood pressure 90 mmHg. 4. History of pathological tachycardia, or a pulse rate > 85 bpm at screening or Day -1. 5. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterise the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a, and to compare to an MDI containing propellant HFA-134a | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: To characterise the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a, and to compare to an MDI containing propellant HFA-134a Pharmacodynamics (PD): To characterise the PD of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a, and to compare to an MDI containing propellant HFA-134a Safety: To characterise the safety and tolerability of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a, and to compare to an MDI containing propellant HFA-134a | — |
Countries
Netherlands
Outcome results
None listed