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Amlodipine/Atorvastatin calcium

Phase 1

Fasting | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Nov 19, 2014

Target and mechanism

ModalitySmall molecule

Also known as Amlodipine

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Amlodipine/Atorvastatin calcium · 8 trials · 3 indications

Phase 1 8
NCT02295046Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting ConditionHealthy
COMPLETED80 Analytics
NCT02292069Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed ConditionHealthy
COMPLETED90 Analytics
NCT01505998Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed ConditionsFed
COMPLETED49 Analytics
NCT01506011Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fasting ConditionsFasting
COMPLETED50 Analytics
NCT01155908Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) ConditionsHealthy
COMPLETED48 Analytics
NCT01155895Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting ConditionsHealthy
COMPLETED54 Analytics
NCT01131923Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fasting ConditionsHealthy
COMPLETED26 Analytics
NCT01131936Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed ConditionsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition
Healthy
NCT0229504680
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PHASE1COMPLETED
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
Healthy
NCT0229206990
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PHASE1COMPLETED
Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions
Fed
NCT0150599849
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PHASE1COMPLETED
Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fasting Conditions
Fasting
NCT0150601150
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PHASE1COMPLETED
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions
Healthy
NCT0115590848
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PHASE1COMPLETED
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions
Healthy
NCT0115589554
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PHASE1COMPLETED
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fasting Conditions
Healthy
NCT0113192326
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PHASE1COMPLETED
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fed Conditions
Healthy
NCT0113193624
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Study Endpoints

Primary Endpoints

Area under curve (AUC)
0.50; 1.00; 2.00; 3.00; 4.00; 5.00; 6.00; 7.00; 8.00; 10.00; 11.00; 12.00 16.00; 24.00; 36.00;48.00 and 72.00 hours post dose for Amlodipine
Bioequivalence is based on Cmax and AUC parameters
3 months
Bioavailability based on Cmax and AUC parameters
2 Months
Bioequivalence based on Cmax and AUC parameters
3 months

Secondary Endpoints

Area under curve (AUC)
10 min; 20 min; 30 min; 40 min; 50 min; 1.00; 1.25; 1.50; 1.75; 2.00; 2.25; 2.50; 2.75; 3.00; 3.50; 4.00; 4.50; 5.00; 6.00; 8.00; 10.00; 12.00 16.00;24.00; 36.00; 48.00 and 72.00 hours post dose for Atorvastatin
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Amlodipine besylate/Atorvastatin calcium tablets 10/80 mgEXPERIMENTALAmlodipine besylate/Atorvastatin calcium tablets 10/80 mg of Dr. Reddys Laboratories Limited
CaduetACTIVE_COMPARATORCaduet® 10/80 mg tablets of Pfizer, Ireland
Amlodipine Besylate/Benazepril HClEXPERIMENTALAmlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules of Dr. Reddy's Laboratories Ltd.
LotrelACTIVE_COMPARATORLotrel® Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules of Novartis Pharmaceuticals
Amlodipine Besylate/Benazepril HydrochlorideEXPERIMENTAL10 mg Amlodipine Besylate/20 mg Benazepril Hydrochloride Capsules of Dr.Reddy's Laboratories Limited
Amlodipine Tablets, 10 mgEXPERIMENTALAmlodipine Tablets, 10 mg of Dr. Reddy's Laboratories Limited
Norvasc Tablets, 10 mgACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Amlodipine besylate/Atorvastatin calciumDRUGAmlodipine besylate/Atorvastatin calcium 10/80 mg
Amlodipine Besylate/Benazepril HClDRUGAmlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules
Amlodipine Besylate / Benazepril HydrochlorideDRUG10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules
AmlodipineDRUGAmlodipine Tablets, 10 mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and female volunteers between 18 and 55 years of age 2. Subject with the Body Mass Index within 18.5 and 24.9 kg/m2, weight not less than 50 kg 3. Normal health as determined by personal medical history, haematology, clinical chemistry and urinalysis laboratory p...

Countries:GermanyIndiaUnited States
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