Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy Subjects
Phase 1
Completed
- Conditions
- Asthma
- Interventions
- Drug: GW685698X & GW642444M
- Registration Number
- NCT00538057
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description arm 1 GW685698X & GW642444M study drug
- Primary Outcome Measures
Name Time Method Electrocardiogram changes over 12 hours. Maximum heart rate over 4 hours after dosing. Blood pressure changes over 12 hours. Change in peak expiry flow rate changes over 24 hours. Change in serum cortisol concentration changes over 24 hours.
- Secondary Outcome Measures
Name Time Method Change in plasma drug concentration (AUC, Cmax, t1/2, tmax) over 48 hours after dosing. Change in blood potassium levels within 4 hours of drug dosing. Mean heart rate over 4 hours after dosing
Trial Locations
- Locations (1)
GSK Investigational Site
🇦🇺Randwick, Sydney, New South Wales, Australia