Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT04856098
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Brief Summary
The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A Indacaterol maleate and glycopyrronium bromide - Part 1 Ultibro Breezhaler 1 capsule, Batch A Indacaterol maleate and glycopyrronium bromide - Part 2 Ultibro Breezhaler 2 capsules, Batch A Indacaterol maleate and glycopyrronium bromide - Part 1 Ultibro Breezhaler 2 capsules, Batch A Indacaterol maleate and glycopyrronium bromide - Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A Ultibro Breezhaler with oral charcoal - Part 2 Ultibro Breezhaler 2 capsules, Batch B Indacaterol maleate and glycopyrronium bromide -
- Primary Outcome Measures
Name Time Method Peak indacaterol concentration in plasma (Cmax) between 0-72 hours after dosing Peak glycopyrronium concentration in plasma (Cmax) between 0-72 hours after dosing Indacaterol area under the concentration-time curve from time zero to 30 minutes (AUC30min) 0-30 minutes after dosing Glycopyrronium area under the concentration-time curve from time zero to 30 minutes (AUC30min) 0-30 minutes after dosing Indacaterol area under the concentration-time curve from time zero to 72 hours (AUC72h) 0-72 hours after dosing Glycopyrronium area under the concentration-time curve from time zero to 72 hours (AUC72h) 0-72 hours after dosing
- Secondary Outcome Measures
Name Time Method Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt) 0-18 days after dosing Glycopyrronium area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt) 0-18 days after dosing Indacaterol area under the concentration-time curve from time zero to infinity (AUCinf) 0-18 days after dosing Glycopyrronium area under the concentration-time curve from time zero to infinity (AUCinf) 0-18 days after dosing Indacaterol terminal elimination half-life (t1/2) 0-18 days after dosing Time to reach peak indacaterol concentration in plasma between 0-72 hours after dosing Time to reach peak glycopyrronium concentration in plasma between 0-72 hours after dosing Number of adverse events as event counts and subjects counts throughout the study, average 9-12 weeks Glycopyrronium terminal elimination half-life (t1/2) 0-18 days after dosing
Trial Locations
- Locations (1)
CRST Helsinki Oy
🇫🇮Helsinki, Finland