Status:
COMPLETED
Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dose.
Eligibility Criteria
Inclusion
- Healthy male and female subjects
- 18-60 years old
- Body mass index \>19 and \<30 kg/m2
- Weight at least 50 kg
- Written informed consent obtained
Exclusion
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
- Any condition requiring regular concomitant treatment.
- Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject.
- Known hypersensitivity to tiotropium bromide, atropine or its derivatives, or lactose.
- Pregnant or lactating females and females of childbearing potential not using proper contraception.
- Blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before the first study treatment administration
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03400241
Start Date
February 19 2018
End Date
April 18 2018
Last Update
June 14 2018
Active Locations (1)
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1
Clinical Pharmacology Unit
Espoo, Finland