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Clopidogrel Bisulfate

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 Enrollment93

FDA Designations

No designations recorded

Clinical trial landscape

Clopidogrel Bisulfate · 2 trials · 1 indication

Phase 1 2
NCT00648947Fasting Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mgHealthy
COMPLETED46 Analytics
NCT00650169Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mgHealthy
COMPLETED47 Analytics
PHASE1COMPLETED
Fasting Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 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
1EXPERIMENTALClopidogrel Bisulfate Tablets 75 mg
2ACTIVE_COMPARATORPlavix® Tablets 75 mg

Interventions

NameTypeDescription
Clopidogrel Bisulfate Tablets 75 mgDRUG75mg, single dose fasting
Plavix® Tablets 75 mgDRUG75mg, single dose fasting
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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 a negative serum (Beta HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administ...

Countries:United States
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