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Zafirlukast

Phase 1

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

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

Clinical trial landscape

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 used for?

Zafirlukast is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being investigated for its pharmacokinetic properties, specifically in a bioequivalence study.

Who makes Zafirlukast?

Zafirlukast is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug's bioequivalence.

What phase is Zafirlukast in?

Zafirlukast is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The current development stage involves early clinical trials in healthy subjects.

What clinical trials is Zafirlukast in?

Zafirlukast is being studied in a completed Phase 1 clinical trial with the identifier NCT01283061. This trial was a bioequivalence study of Zafirlukast tablets 20 mg conducted under fasting conditions in healthy volunteers in India.

Is Zafirlukast the same as any other drug?

Zafirlukast is the drug name used in the clinical trial. No alternative names have been reported for this drug in the available information. It is being studied as a tablet formulation.