Skip to main content
OpenTrials
Completed

NCT Number: NCT05246046

Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler

This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.

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 male and female
  • 18-60 years of age
  • Body mass index 19-30 kg/m2
  • Weight at least 50 kg
  • FEV1 at least 80% of the predicted value measured at screening
  • Written informed consent obtained

Main exclusion criteria:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, 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

In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler

Other names: Tiotropium Easyhaler 10 microg/dose, inhalation powder, Product variant J, Tiotropium Easyhaler 10 microg/dose, inhalation powder, Product variant K, SPIRIVA® 18 microgram, inhalation powder, hard capsule inhaled via HandiHaler

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: between 0-30 minutes after dosing

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

    Time frame: between 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: throughout the study, an average 7 weeks

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Pharmacokinetic Study to Compare Tiotropium Easyhaler® Product Variants and Spiriva® 18 µg Capsules Administered Via HandiHaler® in Healthy Volunteers.

Acronym: TEMPO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2022
Registry last updated
Aug 18, 2022

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.