NCT03400241

Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

Pharmacokinetic Pilot Study Comparing Absorption of Inhaled Tiotropium Between Tiotropium Easyhaler® Products and Spiriva® Capsules Delivered Via HandiHaler®

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Tiotropium Bromide Monohydrate	Tiotropium Easyhaler 10 mcg/dose Product A
DRUG	Tiotropium Bromide Monohydrate	Tiotropium Easyhaler 10 mcg/dose Product B
DRUG	Tiotropium Bromide Monohydrate	Tiotropium Easyhaler 10 mcg/dose Product C
DRUG	Tiotropium Bromide Monohydrate	Spiriva 18 Mcg/capsule inhaled via HandiHaler

Timeline

• Start date: 2018-02-19
• Primary completion: 2018-04-18
• Completion: 2018-04-18
• First posted: 2018-01-17
• Last updated: 2018-06-14

Locations

1 site across 1 country: Finland