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Amlodipine/Atorvastatin calcium

Phase 1

Fasting | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jan 9, 2012

Amlodipine/Atorvastatin calcium target and mechanism

Molecular targetCACNA1C, CACNA1S, CACNA1D, CACNA1F
Target classBlocker
ModalitySmall molecule

Also known as Amlodipine

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment99

FDA Designations

No designations recorded

Amlodipine/Atorvastatin calcium clinical trials

Amlodipine/Atorvastatin calcium · 2 trials · 2 indications

Phase 1 2
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
PHASE1COMPLETED
Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions
FedUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fasting Conditions
FastingUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence is based on Cmax and AUC parameters
3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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

Interventions

NameTypeDescription
Amlodipine Besylate/Benazepril HClDRUGAmlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects will provide written informed consent. * Subjects must be healthy adults within 18-45 years of age (inclusive). * Body mass index of ≥18 kg/m2 and ≤25 kg/m2, with body weight not less than 50 kg. * Subjects must be of normal health as determined by medical history and...

Countries:India
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Frequently asked questions about Amlodipine/Atorvastatin calcium

What is Amlodipine/Atorvastatin calcium?

Amlodipine/Atorvastatin calcium is a small molecule drug candidate developed by Dr. Reddy's Laboratories Ltd (ticker RDY). It has been studied in Phase 1 clinical trials, with one completed trial and no active trials. The program has involved 50 total enrolled participants.

What does Amlodipine/Atorvastatin calcium target?

Amlodipine/Atorvastatin calcium targets CACNA1C, CACNA1S, CACNA1D, and CACNA1F. It is classified as a blocker. These calcium channel targets are associated with its mechanism of action as a small molecule therapeutic.

Who makes Amlodipine/Atorvastatin calcium?

Amlodipine/Atorvastatin calcium is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company has conducted Phase 1 clinical testing of this small molecule candidate.

What phase is Amlodipine/Atorvastatin calcium in?

Amlodipine/Atorvastatin calcium is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA.

What clinical trials is Amlodipine/Atorvastatin calcium in?

Amlodipine/Atorvastatin calcium has been evaluated in two completed Phase 1 bioequivalence trials: NCT01506011 under fasting conditions and NCT01505998 under fed conditions. Both trials were conducted in India with healthy volunteers aged 18 years and older.