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Atorvastatin Calcium

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 20, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials4
Total Enrollment294

FDA Designations

No designations recorded

Clinical trial landscape

Atorvastatin Calcium · 4 trials · 1 indication

Phase 1 4
NCT01645449Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fasting ConditionsHealthy
COMPLETED77 Analytics
NCT01645423Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fed ConditionsHealthy
COMPLETED77 Analytics
NCT01645384Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg Under Fasting ConditionsHealthy
COMPLETED69 Analytics
NCT01645410Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed ConditionsHealthy
COMPLETED71 Analytics
PHASE1COMPLETED
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fasting Conditions
Healthy
NCT0164544977
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PHASE1COMPLETED
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
Healthy
NCT0164542377
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PHASE1COMPLETED
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg Under Fasting Conditions
Healthy
NCT0164538469
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PHASE1COMPLETED
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed Conditions
Healthy
NCT0164541071
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Study Endpoints

Primary Endpoints

Area under curve (AUC)
Pre-dose at 0.00 hour and post-dose at 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00,6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Atorvastatin Calcium Tablets, 80 mgEXPERIMENTALAtorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Laboratories Limited
Lipitor 80 mg TabletsACTIVE_COMPARATORLipitor 80 mg Tablets of Pfizer Ireland Pharmaceuticals
Atorvastatin Calcium Tablets, 40 mgEXPERIMENTALAtorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
Lipitor® 40 mg TabletsACTIVE_COMPARATORLipitor® 40 mg Tablets of Pfizer Ireland Pharmaceuticals

Interventions

NameTypeDescription
Atorvastatin Calcium Tablets, 80 mgDRUGAtorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
Atorvastatin Calcium Tablets, 40 mgDRUGAtorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and female subjects aged 18 - 55 (including) years old. 2. Subjects' weight within normal range according to normal values for Body Mass Index (1 8.0 to 30.0 kg/m2) with minimum of 50 kg weight. 3. Subjects with normal health as determined by personal medical history, cl...

Countries:GermanyIndia
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