Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler® (TESSA)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Easyhaler with oral activated charcoal

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland
    • Clinical Pharmacology Unit, Orion Corporation

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tiotropium Easyhaler Product variant D	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant D; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant E; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant F; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant G; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant H; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 µg/capsule inhaled via Handihaler
EXPERIMENTAL: Tiotropium Easyhaler Product variant E	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant D; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant E; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant F; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant G; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant H; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 µg/capsule inhaled via Handihaler
EXPERIMENTAL: Tiotropium Easyhaler Product variant F	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant D; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant E; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant F; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant G; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant H; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 µg/capsule inhaled via Handihaler
EXPERIMENTAL: Tiotropium Easyhaler Product variant G	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant D; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant E; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant F; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant G; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant H; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 µg/capsule inhaled via Handihaler
EXPERIMENTAL: Tiotropium Easyhaler Product variant H	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant D; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant E; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant F; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant G; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant H; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 µg/capsule inhaled via Handihaler
ACTIVE_COMPARATOR: Spiriva HandiHaler	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant D; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant E; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant F; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant G; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant H; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 µg/capsule inhaled via Handihaler
EXPERIMENTAL: Tiotropium Easyhaler Product variant F administered with oral activated charcoal	Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant D; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant E; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant F; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant G; Drug: Tiotropium Bromide Monohydrate; Tiotropium Easyhaler 10 µg/dose Product variant H; Drug: Tiotropium Bromide Monohydrate; Spiriva 18 µg/capsule inhaled via Handihaler; Drug: Tiotropium Easyhaler with oral activated charcoal; The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak tiotropium concentration in plasma (Cmax)	between 0-72 hours after dosing
Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)	0-30 minutes after dosing
Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)	0-72 hours after dosing

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	througout the study, an average 9 weeks

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2021
• Primary Completion (ACTUAL): October 4, 2021
• Study Completion (ACTUAL): October 4, 2021

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (ACTUAL): April 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

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; Protective Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antidotes; Tiotropium Bromide; Bromides; Charcoal
• Other Study ID Numbers: 3122005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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