Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Easyhaler with oral activated charcoal

• Registration Number: NCT04850144
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-20
• Study Start: 2021-04-26
• Status Verified: 2021-10
• Primary Completion: 2021-10-04
• Study Completion: 2021-10-04
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spiriva HandiHaler	Tiotropium Bromide Monohydrate	-
Tiotropium Easyhaler Product variant F administered with oral activated charcoal	Tiotropium Easyhaler with oral activated charcoal	-
Tiotropium Easyhaler Product variant F	Tiotropium Bromide Monohydrate	-
Tiotropium Easyhaler Product variant G	Tiotropium Bromide Monohydrate	-
Tiotropium Easyhaler Product variant D	Tiotropium Bromide Monohydrate	-
Tiotropium Easyhaler Product variant E	Tiotropium Bromide Monohydrate	-
Tiotropium Easyhaler Product variant H	Tiotropium Bromide Monohydrate	-
Tiotropium Easyhaler Product variant F administered with oral activated charcoal	Tiotropium Bromide Monohydrate	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)	0-72 hours after dosing
Peak tiotropium concentration in plasma (Cmax)	between 0-72 hours after dosing
Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)	0-30 minutes after dosing

Secondary Outcome Measures

Name	Time	Method
Time to reach peak concentration in plasma (tmax)	between 0-72 hours after dosing

Trial Locations

Locations (1)

Clinical Pharmacology Unit, Orion Corporation; 🇫🇮 Espoo, Finland