Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Tiotropium Bromide Monohydrate

• Registration Number: NCT03400241
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-09
• Study First Posted: 2018-01-17
• Study Start: 2018-02-19
• Primary Completion: 2018-04-18
• Study Completion: 2018-04-18
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tiotropium Easyhaler Product B	Tiotropium Bromide Monohydrate	tiotropium bromide monohydrate 2 inhalations as a single dose
Tiotropium Easyhaler Product C	Tiotropium Bromide Monohydrate	tiotropium bromide monohydrate 2 inhalations as a single dose
Spiriva HandiHaler	Tiotropium Bromide Monohydrate	tiotropium bromide monohydrate 2 Spiriva capsules inhaled via HandiHaler
Tiotropium Easyhaler Product A	Tiotropium Bromide Monohydrate	tiotropium bromide monohydrate 2 inhalations as a single dose

Primary Outcome Measures

Name	Time	Method
Peak plasma concentration (Cmax) of tiotropium	between 0-72 hours after dosing
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
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Pharmacology Unit; 🇫🇮 Espoo, Finland