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Montelukast chewable and

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as Montelukast sodium chewable tablets 4mg and 5mg

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment98

FDA Designations

No designations recorded

Clinical trial landscape

Montelukast chewable and · 2 trials · 1 indication

Phase 1 2
NCT01674517Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fed ConditionHealthy
COMPLETED35 Analytics
NCT01674504Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fasting ConditionHealthy
COMPLETED63 Analytics
PHASE1COMPLETED
Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fed Condition
Healthy
NCT0167451735
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PHASE1COMPLETED
Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fasting Condition
Healthy
NCT0167450463
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Study Endpoints

Primary Endpoints

Area under curve(AUC)
Blood samples were withdrawn at predose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, hours post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Montelukast sodiumEXPERIMENTALMontelukast sodium chewable tablets 4mg and 5mg of Dr. Reddy's Laboratories Limited
SINGULAIR®ACTIVE_COMPARATORSINGULAIR®(containing Montelukast sodium) chewable tablets 4mg and 5mg of Merck Sharp \& Dohme Ltd., USA
SINGTJLAIR ®ACTIVE_COMPARATORSINGTJLAIR ® (containing Montelukast sodium)chewable tablets 5mg of Merck Sharp \& Dohme Ltd., USA

Interventions

NameTypeDescription
Montelukast sodium chewable tablets 4mg and 5mgDRUGMontelukast sodium chewable tablets 4mg and 5mg
Montelukast sodium chewable tablets 4 mg and 5 mgDRUGMontelukast sodium chewable tablets 4mg and 5mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects were selected based on the following inclusion criteria: * Provide written informed consent. * Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg. * Having a body mass index between 18.0 and 24.9 (both inclusive)...

Countries:India
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