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Trospium Chloride

Phase 4FDA approved

Undisclosed | Small molecule | Other |AbbVie Inc.|Trials Updated: Dec 19, 2011

Trospium Chloride development status

FDA approval on record May 28, 2004
Approval holderAllergan
ApplicationNDA021595
Highest phase Phase 4 (NCT00863551)
Phase scored for ABBVPhase 1
Registered trials 6 across 3 sponsors since Mar 2009

Trospium Chloride target and mechanism

Molecular targetCHRM2, CHRM3
Target classAntagonist
ModalitySmall molecule

Also known as Trospium Chloride (Sanctura XR®)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Trospium Chloride clinical trials

Trospium Chloride · 1 trial · 1 indication

Phase 1 1
NCT00986401Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy SubjectsHealthy
COMPLETED44 Analytics
PHASE1COMPLETED
Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) Following Oral Administration of Glucophage®
34 Days

Maximum Plasma Level (Cmax) of Metformin Hydrochloride (Glucophage®) following oral administration of Glucophage® alone and in combination with SanturaXR®. Plasma is the fluid portion of the blood.

Secondary Endpoints

Maximum Plasma Level (Cmax) of Trospium Chloride (Sanctura XR®) Following Oral Administration of Sanctura XR®
34 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Glucophage® then Sanctura XR® (AB)EXPERIMENTALTreatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
Sanctura XR® then Glucophage® (BA)EXPERIMENTALTreatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.

Interventions

NameTypeDescription
Trospium Chloride (Sanctura XR®)DRUGextended release, 60 mg, oral daily
Metformin hydrochloride (Glucophage®)DRUGimmediate release, 500mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Weight within +/-30% of ideal body weight for height and frame size * Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 1 months prior to the screening visit). * Willing to abstain from caffeine-containing food and beverages...

Countries:United States
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Frequently asked questions about Trospium Chloride

What is trospium chloride?

Trospium chloride is a small molecule drug developed by AbbVie Inc. (ticker ABBV). It is an antagonist of the CHRM2 and CHRM3 muscarinic acetylcholine receptors. The compound is also known by the brand name Sanctura XR. Its clinical development has included Phase 1 study in healthy volunteers.

What does trospium chloride target?

Trospium chloride targets CHRM2 and CHRM3, two muscarinic acetylcholine receptor subtypes. It acts as an antagonist at these receptors, meaning it blocks receptor activity. This target profile places trospium chloride in the antimuscarinic class of small molecule therapeutics.

Who makes trospium chloride?

Trospium chloride is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company associated with the clinical development program for the drug, including the Phase 1 study conducted in the United States.

What phase is trospium chloride in?

Trospium chloride is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was a randomized, controlled Phase 1 trial in healthy subjects.

What clinical trials is trospium chloride in?

Trospium chloride has been studied in trial NCT00986401, titled Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects. This completed Phase 1 trial enrolled 44 participants in the United States, included both sexes, and required participants to be at least 18 years old.

Is trospium chloride the same as Sanctura XR?

Yes, trospium chloride is also known as Sanctura XR. Sanctura XR is a brand name for trospium chloride, so searches for either name refer to the same drug developed by AbbVie Inc. under ticker ABBV.