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Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

NCT03400241 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-06-14

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 mcg/dose Product A

DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 mcg/dose Product B

DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 mcg/dose Product C

DRUG

Tiotropium Bromide Monohydrate

Spiriva 18 Mcg/capsule inhaled via HandiHaler

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Ulla Sairanen, MSc · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2018-04-18
Completion
2018-04-18

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400241 on ClinicalTrials.gov