Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

Orion Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Tiotropium Bromide Monohydrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03400241

3122002

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Tiotropium Easyhaler Product A

Experimental group

Description:

tiotropium bromide monohydrate 2 inhalations as a single dose

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product B

Experimental group

Description:

tiotropium bromide monohydrate 2 inhalations as a single dose

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Tiotropium Easyhaler Product C

Experimental group

Description:

tiotropium bromide monohydrate 2 inhalations as a single dose

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Spiriva HandiHaler

Active Comparator group

Description:

tiotropium bromide monohydrate 2 Spiriva capsules inhaled via HandiHaler

Treatment:

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate

Drug: Tiotropium Bromide Monohydrate