Healthy Volunteers
Conditions
Brief summary
This is a formulation feasibility study to to compare relative bioavailability of indacaterol and glycopyrronium after administration of single doses of 3 Easyhaler test products and Ultibro Breezhaler. The study treatments will be administered with concomitant oral charcoal to block absorption via gastrointestinal tract and to assess pulmonary absorption only.
Interventions
In each period, subjects receive single dose of indacaterol/glycopyrronium consisting of 2 inhaled doses via Easyhaler or 2 capsules inhaled via Ultibro Breezhaler. In addition to study treatments, activated charcoal will be administered on each study period before and after study drug administration.
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Bioanalytical laboratory will be blinded with regard to the sequence of the product administration.
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 | Description |
|---|---|---|
| Peak indacaterol and glycopyrronium concentration in plasma (Cmax) | between 0-72 hours after dosing | Pharmacokinetic parameters of indacaterol and glycopyrronium |
| Area under the concentration-time curve from time zero to 72 hours (AUC72) | between 0-72 hours after dosing | Pharmacokinetic parameters of indacaterol and glycopyrronium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax) | between 0-72 hours after dosing | Pharmacokinetic parameters of indacaterol and glycopyrronium |
| Area under the concentration-time curve from time zero to 30 minutes (AUC30) | between 0-30 minutes after dosing | Pharmacokinetic parameters of indacaterol and glycopyrronium |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to 11 weeks | Adverse events |
Countries
Finland
Outcome results
None listed