Healthy Volunteer Study
Conditions
Brief summary
The study will assess how efficiently activated charcoal will block absorption of tiotropium via the gastro intestinal track. Pharmacokinetics of tiotropium will be compared after orally administered tiotropium capsule with and without concomitant activated charcoal administration in healthy volunteers.
Interventions
DRUGTiotropium
Oral capsule 20 μg
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent (IC) obtained. 2. Healthy males and females, aged 18-60 3. Normal weight at least 50 kg.
Exclusion criteria
1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease. 2. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. 3. Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study. 4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug. 5. Pregnant or lactating females. 6. Females of childbearing potential not using proper contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetic parameter Area Under Curve (AUC) | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax) | (0 hours) and at 15, 30 and 45 minutes, and 1,1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours after the administration |
Countries
Finland
Outcome results
None listed