Recent Updates
Recently added Catalysts

pravastatin

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2024

Target and mechanism

ModalitySmall molecule

Also known as pravastatin sodium

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment158

FDA Designations

No designations recorded

Clinical trial landscape

pravastatin · 4 trials · 1 indication

Phase 1 4
NCT00830258Pravastatin Sodium 80 mg Tablets Under Fasting ConditionsHealthy
COMPLETED60 Analytics
NCT00829309Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting ConditionsHealthy
COMPLETED16 Analytics
NCT00834379Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting ConditionsHealthy
COMPLETED58 Analytics
NCT00834847Pravastatin Sodium 40 mg Tablets Food Challenge StudyHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Pravastatin Sodium 80 mg Tablets Under Fasting Conditions
Healthy
NCT0083025860
Unlock trial analytics
PHASE1COMPLETED
Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions
Healthy
NCT0082930916
Unlock trial analytics
PHASE1COMPLETED
Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions
Healthy
NCT0083437958
Unlock trial analytics
PHASE1COMPLETED
Pravastatin Sodium 40 mg Tablets Food Challenge Study
Healthy
NCT0083484724
Unlock trial analytics

Study Endpoints

Primary Endpoints

Cmax - Maximum Observed Concentration - Pravastatin in Plasma
Blood samples collected over 16 hour period

Bioequivalence based on Cmax

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Blood samples collected over 16 hour period

Bioequivalence based on AUC0-inf

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Blood samples collected over 16 hour period

Bioequivalence based on AUC0-t

Bioequivalence based on Cmax and AUC
3 weeks
Cmax - Maximum Observed Concentration
Blood samples collected over 24 hour period

Secondary Endpoints

Cmax - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions
Blood samples collected over 24 hour period
AUC0-inf - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions
Blood samples collected over 24 hour period
AUC0-t - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions
Blood samples collected over 24 hour period
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
PravastatinEXPERIMENTALPravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
Pravachol®ACTIVE_COMPARATORPravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
Pravastatin fastEXPERIMENTALTest product under fasting conditions dosed in first period followed by either test or reference product dosed under fed conditions in second and third periods

Interventions

NameTypeDescription
Pravastatin sodium 80 mg tabletsDRUG1 x 80 mg
Pravachol® 80 mg tabletsDRUG1 x 80 mg
PravastatinDRUG80 mg Tablet
pravastatin sodiumDRUG40 mg Tablet
Pravachol®DRUG40 mg tablet
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, non-smoking male and female subjects, 18 years of age or older. * BMI greater than or equal to 19 and less than or equal to 30. * Negative for: * HIV. * Hepatitis B surface antigen and Hepatitis C antibody. * Using drugs of abuse test (marijuana, amphetamines, ...

Countries:CanadaUnited States
Unlock Eligibility Criteria