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Carvedilol

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

Carvedilol · 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
Healthy
NCT0083479536
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PHASE1COMPLETED
Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects
Healthy
NCT0083487324
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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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