Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

• Status: Completed
• Trial end date: 2021-10-04
• Target enrollment: 0
• Participant gender: All

Summary

Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Bromides; Charcoal; Tiotropium Bromide

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, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease

2. Any condition requiring regular concomitant treatment

3. Any clinically significant abnormal laboratory value 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 tiotropium bromide, atropine or its derivatives or lactose

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.