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Cetirizine

Phase 4FDA approved

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

Cetirizine development status

FDA approval on record Aug 10, 2001
Approval holderKenvue Brands
ApplicationNDA021150
Highest phase Phase 4 run by GlaxoSmithKline (NCT01916226)
Phase scored for RDYPhase 1
Registered trials 11 across 7 sponsors since Jun 2007

Cetirizine target and mechanism

Molecular targetHRH1
Target classAntagonist
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

Cetirizine clinical trials

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
HealthyUnlock trial analytics
PHASE1COMPLETED
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
HealthyUnlock trial analytics

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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Frequently asked questions about Cetirizine

What is Cetirizine?

Cetirizine is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in Phase 1 clinical trials. The specific medical conditions it is intended to treat have not been disclosed.

What does Cetirizine target?

Cetirizine targets HRH1, the histamine H1 receptor. It acts as an antagonist at this receptor. By blocking HRH1, cetirizine interferes with histamine signaling, which is the mechanism underlying its pharmacological activity.

Who makes Cetirizine?

Cetirizine is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company whose shares trade under the ticker symbol RDY. The company is responsible for the clinical development of this drug candidate.

What phase is Cetirizine in?

Cetirizine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program consists of two completed trials, with no active trials currently listed.

What clinical trials is Cetirizine in?

Cetirizine has been evaluated in two completed Phase 1 trials. NCT01064115 is a bioequivalence study of cetirizine hydrochloride 10 mg tablets under fed conditions, and NCT01064102 is a bioequivalence study of the same tablets under fasting conditions. Both enrolled 30 healthy male volunteers.

Is Cetirizine the same as Cetirizine Hydrochloride?

Yes, Cetirizine Hydrochloride is another name for Cetirizine. The two names refer to the same drug substance. The clinical trials registered for this asset use the name Cetirizine Hydrochloride.