Recent Updates
Recently added Catalysts

Simvastatin

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Aug 9, 2010

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

Simvastatin · 2 trials · 1 indication

Phase 1 2
NCT01167894Bioequivalence Study of Simvastatin Tablets 80 mg of Dr. Reddy's Under Fasting ConditionHealthy
COMPLETED72 Analytics
NCT01167933Bioequivalence Study of Simvastatin Tablets, 80 mg of Dr. Reddy's Under Fed ConditionsHealthy
COMPLETED44 Analytics
PHASE1COMPLETED
Bioequivalence Study of Simvastatin Tablets 80 mg of Dr. Reddy's Under Fasting Condition
Healthy
NCT0116789472
Unlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Simvastatin Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
Healthy
NCT0116793344
Unlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
4 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SimvastatinEXPERIMENTALSimvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd.
ZocorACTIVE_COMPARATORZocor® 80 mg tablets of Merck \& Co. Inc., USA

Interventions

NameTypeDescription
SimvastatinDRUGSimvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subjects will provide written informed consent. * Subjects must be healthy adults within 18-45 years of age (inclusive) weighing at least 50 kg. * Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-we...

Unlock Eligibility Criteria