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Pravastatin

Phase 4FDA approved

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

Pravastatin development status

FDA approval on record Mar 11, 1998 as Pravachol
Approval holderBristol Myers Squibb
ApplicationNDA019898
Highest phase Phase 4 run by Bristol-Myers Squibb (NCT00529178)
Phase scored for RDYPhase 1
Registered trials 28 across 18 sponsors since Aug 2001

Pravastatin target and mechanism

Molecular targetHMGCR
Target classInhibitor
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

Pravastatin clinical trials

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
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed Conditions
HealthyUnlock trial analytics

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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Frequently asked questions about Pravastatin

What is Pravastatin?

Pravastatin is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in Phase 1 clinical trials. The specific medical conditions it is intended to treat have not been disclosed.

What does Pravastatin target?

Pravastatin targets HMGCR, which stands for HMG-CoA reductase. It acts as an inhibitor of this enzyme. By inhibiting HMGCR, the drug is designed to interfere with a specific biological pathway, though the exact therapeutic application is not publicly detailed.

Who makes Pravastatin?

Pravastatin is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company that trades on the stock exchange under the ticker symbol RDY. The company is responsible for the clinical development of this drug candidate.

What phase is Pravastatin in?

Pravastatin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 trials have been completed, and no active trials are currently listed.

What clinical trials is Pravastatin in?

Pravastatin has been studied in two completed Phase 1 clinical trials. These include NCT01146106, a bioequivalence study under fasting conditions with 43 participants, and NCT01146093, a bioequivalence study under fed conditions with 24 participants. Both trials enrolled healthy volunteers.

Is Pravastatin the same as Pravastatin Sodium?

Yes, Pravastatin is also known as Pravastatin Sodium. The two names refer to the same drug substance. Pravastatin Sodium is the salt form used in the clinical trials and development by Dr. Reddy's Laboratories Ltd.