Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

Phase 1

Completed

• Conditions: Healthy Volunteer Study
• Interventions: Drug: Tiotropium

• Registration Number: NCT03945344
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Study Start: 2019-05-27
• Primary Completion: 2019-06-19
• Study Completion: 2019-06-19
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Tiotropium	Tiotropium with concomitant charcoal
Treatment B	Tiotropium	Tiotropium without concomitant charcoal.

Primary Outcome Measures

Name	Time	Method
The pharmacokinetic parameter Area Under Curve (AUC)	24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Pharmacology Unit; 🇫🇮 Espoo, Finland