Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler® (TESSA)

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Easyhaler with oral activated charcoal

Study type: Interventional

Funder types: Industry

Identifiers

NCT04850144

3122005

Details and patient eligibility

About

Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.

Enrollment: 43 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion criteria:

1. Healthy males and females
2. 18-60 years of age
3. Body mass index 19-30 kg/m2
4. Weight at least 50 kg
5. Written informed consent obtained

Main 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
3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject
4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or lactose
5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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43 participants in 7 patient groups

Tiotropium Easyhaler Product variant D

Experimental group

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant E

Experimental group

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant F

Experimental group

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant G

Experimental group

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant H

Experimental group

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Spiriva HandiHaler

Active Comparator group

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product variant F administered with oral activated charcoal

Experimental group

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Easyhaler with oral activated charcoal