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Quetiapine

Phase 4

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Mar 29, 2012

Quetiapine development status

Highest phase Phase 4 run by Weill Medical College of Cornell University (NCT01244711)
Phase scored for RDYPhase 1
Registered trials 40 across 24 sponsors since Jun 2003

Quetiapine target and mechanism

Molecular targetHTR2A, DRD2, HTR2C
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL716

Also known as Quetiapine fumarate, Seroquel

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Quetiapine clinical trials

Quetiapine · 1 trial · 1 indication

Phase 1 1
NCT01566487Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting ConditionHealthy
COMPLETED54 Analytics
PHASE1COMPLETED
Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under curve(AUC)
Period 1 - Pre-dose in day 3, 4 and 5 and period 2 pre dose in day8,9 and 10 and 0.25,0.5,0.75,1.25,1.5,1.75,2,2.5,3,4,6,8,10 & 12 hrs post-dose on day 5 and day 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Quetiapine fumarate tablets 300 mgEXPERIMENTALQuetiapine fumarate film-coated tablets 300 mg of Dr. Reddy's Laboratories Limited
SeroquelACTIVE_COMPARATORSeroquel film-coated tablets 300 mg of Astrazeneca Pharmaceuticals, USA

Interventions

NameTypeDescription
Quetiapine fumarateDRUGQuetiapine fumarate tablets 300mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Written informed consent for participation in the study by the patient and Patient's Legally Acceptable Representative (LAR). If the patient or his/her legally acceptable representative is unable to read/write - an impartial witness should be present during the entire informed...

Countries:India
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Frequently asked questions about Quetiapine

What is Quetiapine?

Quetiapine is a small molecule drug candidate developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is also known as quetiapine fumarate. The drug is currently in Phase 1 clinical development, and its specific indications are undisclosed.

What does Quetiapine target?

Quetiapine targets the serotonin receptor HTR2A, the dopamine receptor DRD2, and the serotonin receptor HTR2C. It acts as an antagonist at these targets. This mechanism of action is characteristic of its pharmacological class.

Who is developing Quetiapine?

Quetiapine is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company that trades under the ticker symbol RDY. The company is responsible for the clinical development of this drug candidate.

What phase is Quetiapine in?

Quetiapine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The development program includes one completed Phase 1 trial.

What clinical trials is Quetiapine in?

Quetiapine has been studied in one completed Phase 1 clinical trial, NCT01566487, titled 'Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition.' This trial enrolled 54 healthy volunteers in India and was active-controlled and randomized.

Is Quetiapine the same as quetiapine fumarate?

Yes, Quetiapine is also known as quetiapine fumarate. The two names refer to the same drug candidate developed by Dr. Reddy's Laboratories Ltd.