Skip to main content
OpenTrials
Completed

NCT Number: NCT04850144

Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit, Orion Corporation

Espoo, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main inclusion criteria:

  • Healthy males and females
  • 18-60 years of age
  • Body mass index 19-30 kg/m2
  • Weight at least 50 kg
  • Written informed consent obtained

Main 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 could interfere with the interpretation of study results or cause 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 contraception of acceptable effectiveness
  • Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.

Treatment and study plan

Tiotropium Bromide Monohydrate

Drug

Tiotropium Easyhaler 10 µg/dose Product variant D

Tiotropium Easyhaler with oral activated charcoal

Drug

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

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

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Acronym: TESSA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2021
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.