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OpenTrials
Completed

NCT Number: NCT03400241

Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva 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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit

Espoo, Finland

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Tiotropium Bromide Monohydrate

Drug

Tiotropium Easyhaler 10 mcg/dose Product A

Primary outcomes

  1. Peak plasma concentration (Cmax) of tiotropium

    Time frame: between 0-72 hours after dosing

  2. Area under the concentration-time curve (AUC) of tiotropium from time zero to 72 h after the study treatment administration

    Time frame: 0-72 hours after dosing

  3. Truncated area under the concentration-time curve (AUC) of tiotropium from time zero to 30 min after study treatment administration

    Time frame: 0-30 minutes after dosing

Secondary outcomes

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

    Time frame: between 0-72 hours after dosing

Other outcomes

  1. Adverse events

    Time frame: throughout the study, an average of 10 weeks

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2018
Registry last updated
Jun 14, 2018

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.

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