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Clopidogrel

Phase 1

Fasting | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 25, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment121

FDA Designations

No designations recorded

Clinical trial landscape

Clopidogrel · 4 trials · 2 indications

Phase 1 4
NCT01621763Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fed ConditionsHealthy
COMPLETED68 Analytics
NCT01621750Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting ConditionsFasting
COMPLETED68 Analytics
NCT01512485Bioequivalence Study of Clopidogrel Tablets 75 mg Under Fed ConditionsHealthy
COMPLETED51 Analytics
NCT01506713Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting ConditionsFasting
COMPLETED53 Analytics
PHASE1COMPLETED
Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fed Conditions
Healthy
NCT0162176368
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PHASE1COMPLETED
Bioequivalence Study of Clopidogrel Tablets 300 mg Under Fasting Conditions
Fasting
NCT0162175068
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PHASE1COMPLETED
Bioequivalence Study of Clopidogrel Tablets 75 mg Under Fed Conditions
Healthy
NCT0151248551
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PHASE1COMPLETED
Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions
Fasting
NCT0150671353
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Study Endpoints

Primary Endpoints

Area under curve(AUC)
at pre-dose 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 3.00, 4.00, 6.00, 8.00, 12.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post dose
Area Under Curve (AUC)
predose, 0.250, 0.500, 0.750, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.0, 16.0, and 24.0 hours post-dose
Bioequivalence is based on Cmax and AUC parameters
1 month
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ClopidogrelEXPERIMENTALClopidogrel tablets 300 mg of Dr. Reddy's Laboratories Limited
PlavixACTIVE_COMPARATORClopidogrel Tablet 300 mg

Interventions

NameTypeDescription
ClopidogrelDRUGClopidogrel Tablets 300 mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult human male volunteers between 18 and 55 years of age (both inclusive) living in and around Ahmedabad city of western part of India. * Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in kg/height in m2. * Not having any ...

Countries:IndiaCanada
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