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Coreg

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Coreg · 2 trials · 1 indication

Phase 1 2
NCT00648622Fed Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mgHealthy
COMPLETED50 Analytics
NCT00650416Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mgHealthy
COMPLETED50 Analytics
PHASE1COMPLETED
Fed Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCarvedilol Tablets 12.5 mg
2ACTIVE_COMPARATORCoreg® Tablets 12.5 mg

Interventions

NameTypeDescription
Carvedilol Tablets 12.5 mgDRUG12.5mg, single dose fed
Coreg® Tablets 12.5 mgDRUG12.5mg, single dose fed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ev...

Countries:United States
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Frequently asked questions about Coreg

What is Coreg used for?

Coreg is a small molecule drug being developed by Viatris Inc. (VTRS) for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies evaluating the drug in healthy individuals. Coreg is not approved for any indication and remains investigational.

Who makes Coreg?

Coreg is developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy volunteers.

What phase is Coreg in?

Coreg is in Phase 1 clinical development. Two Phase 1 trials have been completed, both enrolling healthy volunteers in the United States. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Coreg in?

Coreg has two completed Phase 1 trials: NCT00648622, a fed study comparing carvedilol tablets 12.5 mg to Coreg tablets 12.5 mg, and NCT00650416, a fasting study with the same comparison. Both enrolled 50 healthy volunteers each in the United States.

Is Coreg the same as carvedilol?

Coreg is a brand name for carvedilol. The clinical trials for Coreg compare carvedilol tablets to Coreg tablets, indicating that carvedilol is the active ingredient in Coreg. Both are being studied in healthy volunteers.