Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

Healthy Volunteer Study Clinical Trial

— TIOBLOCK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945344
• Other study ID #: 3122003
• Status: Completed
• Phase: Phase 1
• Start date: May 27, 2019
• Est. completion date: June 19, 2019

Study information

• Verified date: September 2019
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Written informed consent (IC) obtained.

2. Healthy males and females, aged 18-60

3. Normal weight at least 50 kg.

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 (including vitamins and herbal products) or likely to need any concomitant treatment during the study.

3. 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.

4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug.

5. Pregnant or lactating females.

6. Females of childbearing potential not using proper contraception.

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• Tiotropium
Oral capsule 20 µg
• Tiotropium
Oral capsule 20 µg

Locations

Country	Name	City	State
Finland	Clinical Pharmacology Unit	Espoo

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacokinetic parameter Area Under Curve (AUC)		24 hours
Secondary	Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax)		(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