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Cetirizine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Feb 8, 2010

Target and mechanism

ModalitySmall molecule

Also known as Cetirizine Hydrochloride

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Cetirizine · 2 trials · 1 indication

Phase 1 2
NCT01064102Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting ConditionHealthy
COMPLETED30 Analytics
NCT01064115Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed ConditionHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition
Healthy
NCT0106410230
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PHASE1COMPLETED
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
Healthy
NCT0106411530
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Study Endpoints

Primary Endpoints

Bio-equivalence study of Dr Reddys Laboratories Cetirizine Hydrochloride Tablets 10 mg
2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CetirizineEXPERIMENTALCetirizine Hydrochloride Tablets 10 mg of Dr. Reddys Laboratories Limited
ZyrtecACTIVE_COMPARATORZyrtec Tablets 10 mg of Pfizer Labs

Interventions

NameTypeDescription
Cetirizine HydrochlorideDRUGCetirizine Hydrochloride Tablets 10 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: 1. Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India. 2. Having a Body Mass Index (BMI) between 18.5 and 24.9 {both inclusive), calculated as weight in kg/height in m2 3. Not having any significant diseases...

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