Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2018-04-18

Brief Summary

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Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dose.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tiotropium Easyhaler Product A

tiotropium bromide monohydrate 2 inhalations as a single dose

Group Type EXPERIMENTAL

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Tiotropium Easyhaler 10 mcg/dose Product A

Tiotropium Easyhaler Product B

tiotropium bromide monohydrate 2 inhalations as a single dose

Group Type EXPERIMENTAL

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Tiotropium Easyhaler 10 mcg/dose Product B

Tiotropium Easyhaler Product C

tiotropium bromide monohydrate 2 inhalations as a single dose

Group Type EXPERIMENTAL

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Tiotropium Easyhaler 10 mcg/dose Product C

Spiriva HandiHaler

tiotropium bromide monohydrate 2 Spiriva capsules inhaled via HandiHaler

Group Type ACTIVE_COMPARATOR

Tiotropium Bromide Monohydrate

Intervention Type DRUG

Spiriva 18 Mcg/capsule inhaled via HandiHaler

Interventions

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Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 mcg/dose Product A

Intervention Type DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 mcg/dose Product B

Intervention Type DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 mcg/dose Product C

Intervention Type DRUG

Tiotropium Bromide Monohydrate

Spiriva 18 Mcg/capsule inhaled via HandiHaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects
* 18-60 years old
* Body mass index \>19 and \<30 kg/m2
* Weight at least 50 kg
* Written informed consent obtained

Exclusion Criteria

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
* Any condition requiring regular concomitant treatment.
* Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject.
* Known hypersensitivity to tiotropium bromide, atropine or its derivatives, or lactose.
* Pregnant or lactating females and females of childbearing potential not using proper contraception.
* Blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before the first study treatment administration

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes