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Quetiapine

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as Quetiapine fumarate

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

Clinical trial landscape

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
Healthy
NCT0156648754
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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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