Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler

Healthy Volunteers Clinical Trial

— TEMPO  

Official title:

Pharmacokinetic Study to Compare Tiotropium Easyhaler® Product Variants and Spiriva® 18 µg Capsules Administered Via HandiHaler® in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246046
• Other study ID #: 3122006
• Status: Completed
• Phase: Phase 1
• Start date: February 16, 2022
• Est. completion date: August 3, 2022

Study information

• Verified date: August 2022
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Main inclusion criteria:

1. Healthy male and female

2. 18-60 years of age

3. Body mass index 19-30 kg/m2

4. Weight at least 50 kg

5. FEV1 at least 80% of the predicted value measured at screening

6. Written informed consent obtained

Main exclusion criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, 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
In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler

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		throughout the study, an average 7 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)		between 0-30 minutes after dosing
Primary	Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)		between 0-72 hours after dosing
Secondary	Time to reach peak concentration in plasma (tmax)		between 0-72 hours after dosing