MedTrace Logo

Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®

NCT04850144 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-10-25

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant D

DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant E

DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant F

DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant G

DRUG

Tiotropium Bromide Monohydrate

Tiotropium Easyhaler 10 µg/dose Product variant H

DRUG

Tiotropium Bromide Monohydrate

Spiriva 18 µg/capsule inhaled via Handihaler

DRUG

Tiotropium Easyhaler with oral activated charcoal

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

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Orion Corporation Clinical Study Director · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2021-10-04
Completion
2021-10-04

Countries

  • Finland

Study Locations

More Related Trials

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 NCT04850144 on ClinicalTrials.gov