Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Bromide Monohydrate

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland
    • Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tiotropium Easyhaler Product A; tiotropium bromide monohydrate 2 inhalations as a single dose	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product A; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product B; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product C; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 Mcg/capsule inhaled via HandiHaler
Experimental: Tiotropium Easyhaler Product B; tiotropium bromide monohydrate 2 inhalations as a single dose	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product A; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product B; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product C; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 Mcg/capsule inhaled via HandiHaler
Experimental: Tiotropium Easyhaler Product C; tiotropium bromide monohydrate 2 inhalations as a single dose	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product A; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product B; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product C; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 Mcg/capsule inhaled via HandiHaler
Active Comparator: Spiriva HandiHaler; tiotropium bromide monohydrate 2 Spiriva capsules inhaled via HandiHaler	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product A; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product B; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 mcg/dose Product C; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 Mcg/capsule inhaled via HandiHaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak plasma concentration (Cmax) of tiotropium	between 0-72 hours 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
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 Outcome Measures

Outcome Measure	Time Frame
Time to reach peak concentration in plasma (tmax) of tiotropium	between 0-72 hours after dosing

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	throughout the study, an average of 10 weeks

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Actual): April 18, 2018
• Study Completion (Actual): April 18, 2018

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 13, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Bromides
• Other Study ID Numbers: 3122002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No