NCT04850144

Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

Comparison of Tiotropium Pharmacokinetics After Inhalation From Tiotropium Easyhaler® Product Variants and After Spiriva® Capsules Administered Via HandiHaler®; Study in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (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 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Tiotropium Bromide Monohydrate	Tiotropium Easyhaler 10 µg/dose Product variant D
DRUG	Tiotropium Bromide Monohydrate	Tiotropium Easyhaler 10 µg/dose Product variant E
DRUG	Tiotropium Bromide Monohydrate	Tiotropium Easyhaler 10 µg/dose Product variant F
DRUG	Tiotropium Bromide Monohydrate	Tiotropium Easyhaler 10 µg/dose Product variant G
DRUG	Tiotropium Bromide Monohydrate	Tiotropium Easyhaler 10 µg/dose Product variant H
DRUG	Tiotropium Bromide Monohydrate	Spiriva 18 µg/capsule inhaled via Handihaler
DRUG	Tiotropium Easyhaler with oral activated charcoal	The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F

Timeline

• Start date: 2021-04-26
• Primary completion: 2021-10-04
• Completion: 2021-10-04
• First posted: 2021-04-20
• Last updated: 2021-10-25

Locations

1 site across 1 country: Finland