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COREG

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

COREG · 2 trials · 1 indication

Phase 1 2
NCT00834795Carvedilol 25 mg in 36 Fasted, Healthy, Adult SubjectsHealthy
COMPLETED36 Analytics
NCT00834873Carvedilol (25 mg) in 24 Fed, Healthy, Adult SubjectsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax - Maximum Observed Concentration - Carvedilol in Plasma
Blood samples collected over 60 hour period

Bioequivalence based on Cmax

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma
Blood samples collected over 60 hour period

Bioequivalence based on AUC0-inf

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma
Blood samples collected over 60 hour period

Bioequivalence based on AUC0-t

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
CarvedilolEXPERIMENTALCarvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
Coreg®ACTIVE_COMPARATORCoreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period

Interventions

NameTypeDescription
Carvedilol 25 mg tabletsDRUG1 x 25 mg
COREG® 25 mg tabletsDRUG1 x 25 mg
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Eligibility Criteria

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

Inclusion Criteria: * Sex: Male of Female; similar proportions of each preferred. * Age: At least 18 years. * Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30. Exclusion Criteria: * Subjects not complying with the above inclusion criteria must be excluded from the study. ...

Countries:United States
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Frequently asked questions about COREG

What is COREG?

COREG is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development for use in healthy subjects. The drug is being studied in two completed clinical trials with a total enrollment of 60 participants.

What is COREG used for?

COREG is being studied for use in healthy subjects. It is currently in Phase 1 clinical development, with two completed trials that enrolled healthy adult volunteers. The drug is not yet approved for any medical condition and remains investigational.

Who makes COREG?

COREG is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials of the drug in healthy subjects in the United States.

What phase is COREG in?

COREG is in Phase 1 clinical development. It has completed two Phase 1 trials, both of which enrolled healthy adult subjects. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is COREG in?

COREG has been studied in two completed Phase 1 clinical trials: NCT00834795, which enrolled 36 fasted healthy subjects, and NCT00834873, which enrolled 24 fed healthy subjects. Both trials were conducted in the United States with participants aged 18 years and older.

Is COREG the same as carvedilol?

COREG is a brand name for the drug carvedilol. The clinical trials for COREG, NCT00834795 and NCT00834873, are titled as studies of carvedilol 25 mg in healthy adult subjects, indicating that COREG and carvedilol refer to the same medication.