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Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

NCT ID: NCT04850144

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2021-10-04

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study is a 2-part 4-period crossover study where the study subjects participate either in part 1 (20 subjects) or in part 2 (20 subjects). Parts can run in sequence or parallel. All study subjects receive single dose of Tiotropium Easyhaler on 3 periods and Spiriva HandiHaler on 1 period.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Bioanalytical laboratory will be blinded with regard to the sequence of the product administration.

Study Groups

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Tiotropium Easyhaler Product variant D

Group Type EXPERIMENTAL

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Tiotropium Easyhaler 10 µg/dose Product variant D

Tiotropium Easyhaler Product variant E

Group Type EXPERIMENTAL

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Tiotropium Easyhaler 10 µg/dose Product variant E

Tiotropium Easyhaler Product variant F

Group Type EXPERIMENTAL

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Tiotropium Easyhaler 10 µg/dose Product variant F

Tiotropium Easyhaler Product variant G

Group Type EXPERIMENTAL

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Tiotropium Easyhaler 10 µg/dose Product variant G

Tiotropium Easyhaler Product variant H

Group Type EXPERIMENTAL

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Tiotropium Easyhaler 10 µg/dose Product variant H

Spiriva HandiHaler

Group Type ACTIVE_COMPARATOR

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Spiriva 18 µg/capsule inhaled via Handihaler

Tiotropium Easyhaler Product variant F administered with oral activated charcoal

Group Type EXPERIMENTAL

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Tiotropium Easyhaler 10 µg/dose Product variant F

Tiotropium Easyhaler with oral activated charcoal

Intervention Type DRUG

The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F

Interventions

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Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant D

Intervention Type DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant E

Intervention Type DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant F

Intervention Type DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant G

Intervention Type DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant H

Intervention Type DRUG

Tiotropium Bromide Monohydrate

Spiriva 18 µg/capsule inhaled via Handihaler

Intervention Type DRUG

Tiotropium Easyhaler with oral activated charcoal

The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Orion Corporation Clinical Study Director

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Locations

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Clinical Pharmacology Unit, Orion Corporation

Espoo, , Finland

Site Status

Countries

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Finland

Other Identifiers

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3122005

Identifier Type: -

Identifier Source: org_study_id