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CompletedNCT04850144TESSAUpdated Oct 25, 2021

Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

A Phase 1 interventional study of Tiotropium Bromide Monohydrate and Tiotropium Bromide Monohydrate in Healthy Volunteers, sponsored by Orion Corporation, Orion Pharma. Completed at 1 site in Finland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-25.

Sponsored by Orion Corporation, Orion Pharma · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Tiotropium Easyhaler Product variant D

    Drug: Tiotropium Bromide Monohydrate

  • Experimental
    Tiotropium Easyhaler Product variant E

    Drug: Tiotropium Bromide Monohydrate

  • Experimental
    Tiotropium Easyhaler Product variant F

    Drug: Tiotropium Bromide Monohydrate

  • Experimental
    Tiotropium Easyhaler Product variant G

    Drug: Tiotropium Bromide Monohydrate

  • Experimental
    Tiotropium Easyhaler Product variant H

    Drug: Tiotropium Bromide Monohydrate

  • Active comparator
    Spiriva HandiHaler

    Drug: Tiotropium Bromide Monohydrate

  • Experimental
    Tiotropium Easyhaler Product variant F administered with oral activated charcoal

    Drug: Tiotropium Bromide Monohydrate · Drug: Tiotropium Easyhaler with oral activated charcoal

Interventions

  • DrugTiotropium Bromide Monohydrate

    Tiotropium Easyhaler 10 µg/dose Product variant D

  • DrugTiotropium Bromide Monohydrate

    Tiotropium Easyhaler 10 µg/dose Product variant E

  • DrugTiotropium Bromide Monohydrate

    Tiotropium Easyhaler 10 µg/dose Product variant F

  • DrugTiotropium Bromide Monohydrate

    Tiotropium Easyhaler 10 µg/dose Product variant G

  • DrugTiotropium Bromide Monohydrate

    Tiotropium Easyhaler 10 µg/dose Product variant H

  • DrugTiotropium Bromide Monohydrate

    Spiriva 18 µg/capsule inhaled via Handihaler

  • DrugTiotropium Easyhaler with oral activated charcoal

    The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F

06

What researchers measure

Primary outcomes

  1. Peak tiotropium concentration in plasma (Cmax)

    Time frame: between 0-72 hours after dosing

  2. Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)

    Time frame: 0-30 minutes after dosing

  3. Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)

    Time frame: 0-72 hours after dosing

Secondary outcomes

  1. Time to reach peak concentration in plasma (tmax)

    Time frame: between 0-72 hours after dosing

Other outcomes

  1. Adverse events

    Time frame: througout the study, an average 9 weeks

07

Study locations

1 site
  • Clinical Pharmacology Unit, Orion Corporation
    Espoo, Finland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04850144
Lead sponsor
Orion Corporation, Orion Pharma
Responsible party
Sponsor
First posted
Apr 20, 2021
Start date
Apr 26, 2021
Primary completion
Oct 4, 2021
Completion
Oct 4, 2021
Last update
Oct 25, 2021

Study contacts

Orion Corporation Clinical Study Director
study director · Orion Corporation, Orion Pharma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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