Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

• Status: Completed
• Trial end date: 2018-04-18
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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