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Zafirlukast

Phase 1

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jan 26, 2011

Zafirlukast development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2011

Zafirlukast target and mechanism

Molecular targetCYSLTR1
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL603

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Zafirlukast clinical trials

Zafirlukast · 1 trial · 1 indication

Phase 1 1
NCT01283061Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting ConditionHealthy
COMPLETED44 Analytics
PHASE1COMPLETED
Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
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Study Endpoints

Primary Endpoints

Bioequivalence on Cmax and AUC parameters
13 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
zafirlukastEXPERIMENTALZafirlukast Tablets 20 mg of Dr. Reddys Laboratories Limited
AccolateACTIVE_COMPARATORACCOLATE tablets manufactured by IPR pharmaceuticals and manufactured for Astrazeneca Pharmaceuticals

Interventions

NameTypeDescription
ZafirlukastDRUGZafirlukast tablets 20 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. The subjects should be healthy human between 18 and 45 years. 2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug. 3. The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter. 4. The subjects...

Countries:India
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Frequently asked questions about Zafirlukast

What is Zafirlukast?

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

What does Zafirlukast target?

Zafirlukast targets CYSLTR1, a receptor protein. It acts as an antagonist at this target, meaning it blocks the receptor's activity. This mechanism is characteristic of small molecule drugs in its class.

Who makes Zafirlukast?

Zafirlukast is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company whose shares trade under the ticker symbol RDY. The company is responsible for its clinical development.

What phase is Zafirlukast in?

Zafirlukast is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The only recorded trial is a completed Phase 1 study.

What clinical trials is Zafirlukast in?

Zafirlukast has been studied in one clinical trial: NCT01283061, titled "Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition." This Phase 1 trial was completed and enrolled 44 healthy volunteers in India.