Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400241
• Other study ID #: 3122002
• Status: Completed
• Phase: Phase 1
• Start date: February 19, 2018
• Est. completion date: April 18, 2018

Study information

• Verified date: June 2018
• 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 three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy male and female subjects

• 18-60 years old

• Body mass index >19 and <30 kg/m2

• Weight at least 50 kg

• Written informed consent obtained

Exclusion Criteria:

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease.

• Any condition requiring regular concomitant treatment.

• Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject.

• Known hypersensitivity to tiotropium bromide, atropine or its derivatives, or lactose.

• Pregnant or lactating females and females of childbearing potential not using proper contraception.

• Blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before the first study treatment administration

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Tiotropium Bromide Monohydrate
Tiotropium Easyhaler 10 mcg/dose Product A
• Tiotropium Bromide Monohydrate
Tiotropium Easyhaler 10 mcg/dose Product B
• Tiotropium Bromide Monohydrate
Tiotropium Easyhaler 10 mcg/dose Product C
• Tiotropium Bromide Monohydrate
Spiriva 18 Mcg/capsule inhaled via HandiHaler

Locations

Country	Name	City	State
Finland	Clinical Pharmacology Unit	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 of 10 weeks
Primary	Peak plasma concentration (Cmax) of tiotropium		between 0-72 hours after dosing
Primary	Area under the concentration-time curve (AUC) of tiotropium from time zero to 72 h after the study treatment administration		0-72 hours after dosing
Primary	Truncated area under the concentration-time curve (AUC) of tiotropium from time zero to 30 min after study treatment administration		0-30 minutes after dosing
Secondary	Time to reach peak concentration in plasma (tmax) of tiotropium		between 0-72 hours after dosing