Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

Healthy Volunteers Clinical Trial

— TESSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04850144
• Other study ID #: 3122005
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2021
• Est. completion date: October 4, 2021

Study information

• Verified date: October 2021
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 4, 2021
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Finland	Clinical Pharmacology Unit, Orion Corporation	Espoo

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		througout the study, an average 9 weeks
Primary	Peak tiotropium concentration in plasma (Cmax)		between 0-72 hours after dosing
Primary	Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)		0-30 minutes after dosing
Primary	Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)		0-72 hours after dosing
Secondary	Time to reach peak concentration in plasma (tmax)		between 0-72 hours after dosing