Healthy Volunteers
Conditions
Brief summary
The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.
Interventions
Batch A Ultibro Breezhaler 85/43 μg 2 capsules
DRUGUltibro Breezhaler with oral charcoal
Activated charcoal suspension, granules 50 g / bottle
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The study is a 2-part crossover study where the study subjects participate either in part 1 (18 subjects) or in part 2 (16 subjects). The parts can run in sequence or in parallel. The study subjects in part 1 receive single doses of Ultibro Breezhaler on 3 periods and the study subjects in part 2 receive single doses of Ultibro Breezhaler on 2 periods.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Main inclusion criteria: 1. Healthy males and females 2. 18-60 years of age 3. Body mass index 19-30 kg/m2 4. Weight at least 50 kg 5. Written informed consent obtained Main
Exclusion criteria
1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease 2. Any condition requiring regular concomitant treatment 3. Any clinically significant abnormal laboratory value, vital sign or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject 4. Known hypersensitivity to indacaterol or glycopyrronium 5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness 6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Indacaterol terminal elimination half-life (t1/2) | 0-18 days after dosing |
| Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt) | 0-18 days 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 |
| 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 |
| 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 |
Countries
Finland
Outcome results
None listed