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Completed

NCT Number: NCT03945344

Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

The study will assess how efficiently activated charcoal will block absorption of tiotropium via the gastro intestinal track. Pharmacokinetics of tiotropium will be compared after orally administered tiotropium capsule with and without concomitant activated charcoal administration in healthy volunteers.

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Key information

Conditions

Healthy Volunteer Study

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

  • Written informed consent (IC) obtained.
  • Healthy males and females, aged 18-60
  • Normal weight at least 50 kg.

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 (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
  • Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study.
  • Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug.
  • Pregnant or lactating females.
  • Females of childbearing potential not using proper contraception.

Treatment and study plan

Tiotropium

Drug

Oral capsule 20 μg

Primary outcomes

  1. The pharmacokinetic parameter Area Under Curve (AUC)

    Time frame: 24 hours

Secondary outcomes

  1. Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax)

    Time frame: (0 hours) and at 15, 30 and 45 minutes, and 1,1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours after the administration

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Effect of Charcoal on Gastrointestinal Absorption of Tiotropium; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Acronym: TIOBLOCK

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 10, 2019
Registry last updated
Sep 23, 2019

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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