Effect of Charcoal on Gastrointestinal Absorption of Tiotropium (TIOBLOCK)

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT03945344

3122003

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Treatment A

Experimental group

Description:

Tiotropium with concomitant charcoal

Treatment:

Drug: Tiotropium

Drug: Tiotropium

Treatment B

Experimental group

Description:

Tiotropium without concomitant charcoal.

Treatment:

Drug: Tiotropium

Drug: Tiotropium