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Pravastatin

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 13, 2012

Target and mechanism

ModalitySmall molecule

Also known as Pravastatin Sodium

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

Pravastatin · 2 trials · 1 indication

Phase 1 2
NCT01146106Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting ConditionsHealthy
COMPLETED43 Analytics
NCT01146093Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed ConditionsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions
Healthy
NCT0114610643
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PHASE1COMPLETED
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed Conditions
Healthy
NCT0114609324
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Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
1 month
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pravastatin Sodium Tablets 80 mgEXPERIMENTALDr.Reddy's Laboratories Limited
Pravachol 80 mg TabletsACTIVE_COMPARATORBristol Myers Squibb

Interventions

NameTypeDescription
Pravastatin SodiumDRUGPravastatin Sodium Tablets 80 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy males and females at least 18 years of age. * Informed of the nature of the study and given written informed consent. * Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs. (Append...

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