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Plavix

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

Plavix · 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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Frequently asked questions about Plavix

What is Plavix used for?

Plavix is a small molecule drug being developed by Viatris Inc. (VTRS). In the clinical trials listed, it is studied in healthy volunteers for bioequivalence purposes, comparing clopidogrel bisulfate tablets to Plavix tablets. The indication is listed as Healthy, meaning the trials enroll healthy participants rather than patients with a specific disease.

Who makes Plavix?

Plavix is developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The clinical trials are conducted in the United States and involve healthy volunteers.

What phase is Plavix in?

Plavix is in Phase 1 clinical development. The two trials listed are both Phase 1 studies, and both have been completed. There are no active trials currently listed for Plavix.

What clinical trials is Plavix in?

Plavix has two completed Phase 1 trials: NCT00648947, a fasting study of clopidogrel bisulfate tablets 75 mg compared to Plavix tablets 75 mg, and NCT00650169, a food study of the same comparison. Both enrolled healthy volunteers in the United States, with a total enrollment of 93 participants.

Is Plavix the same as clopidogrel bisulfate?

Plavix is the brand name for clopidogrel bisulfate. The clinical trials compare generic clopidogrel bisulfate tablets to the Plavix brand tablets to assess bioequivalence. The trials are designed to show that the generic version works the same as the branded Plavix.