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tiotropium pMDI

Phase 1

Healthy | Small molecule | Other |Solventum Corporation|Last Updated: Dec 2, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

tiotropium pMDI · 1 trial · 1 indication

Early Phase 1 1
NCT03155204Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference ProductHealthy
COMPLETED46 Analytics
EARLY_PHASE1COMPLETED
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product
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Study Endpoints

Primary Endpoints

Peak Plasma Concentration (Cmax)
24 hr

noncompartmental analysis

Secondary Endpoints

Adverse events
24 hr
Area Under the Plasma Concentration vs Time Curve (AUC)
24 hr
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Test Product 1EXPERIMENTALtiotropium pMDI 2 inhalations
Test Product 2EXPERIMENTALtiotropium pMDI 2 inhalations
Test Product 3EXPERIMENTALtiotropium pMDI 2 inhalations
Test Product 4EXPERIMENTALtiotropium pMDI 2 inhalations
Commercial ProductACTIVE_COMPARATORtiotropium Respimat 2 inhalations

Interventions

NameTypeDescription
tiotropium pMDIDRUGinhalation
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Volunteer * Willing and able to give informed consent * Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic * Subjects must agree to use an adequate method of contraception ...

Countries:United Kingdom
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Frequently asked questions about tiotropium pMDI

What is tiotropium pMDI?

Tiotropium pMDI is an investigational small molecule being developed by Solventum Corporation (NYSE: SOLV). It is a metered-dose inhaler formulation of tiotropium. As of the available data, it is in early clinical development, having completed a Phase 1 trial in healthy volunteers.

What is tiotropium pMDI used for?

Tiotropium pMDI is being studied in healthy volunteers. The completed clinical trial evaluated its pharmacokinetics compared to a reference product. Its use in specific disease conditions has not been established in the available data.

Who makes tiotropium pMDI?

Tiotropium pMDI is being developed by Solventum Corporation, which trades on the New York Stock Exchange under the ticker SOLV. The company is conducting clinical research on this inhaled formulation of tiotropium.

What phase is tiotropium pMDI in?

Tiotropium pMDI is in Phase 1 clinical development. A single early Phase 1 trial has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is tiotropium pMDI in?

Tiotropium pMDI has one completed clinical trial, NCT03155204, titled "Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product." This early Phase 1 study enrolled 46 healthy participants in the United Kingdom.

Is tiotropium pMDI the same as tiotropium?

Tiotropium pMDI is a metered-dose inhaler formulation of the drug tiotropium. The clinical trial compared its pharmacokinetics to a reference tiotropium product. The pMDI designation refers to the specific delivery device used to administer the medication.