Recent Updates
Recently added Catalysts

Montelukast

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Sep 24, 2012

Target and mechanism

ModalitySmall molecule

Also known as Montelukast sodium

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

Montelukast · 4 trials · 1 indication

Phase 1 4
NCT01691456Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting ConditionHealthy
COMPLETED45 Analytics
NCT01691469Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed ConditionHealthy
COMPLETED31 Analytics
NCT01671709Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting ConditionHealthy
COMPLETED41 Analytics
NCT01671722Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed ConditionHealthy
COMPLETED43 Analytics
PHASE1COMPLETED
Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting Condition
Healthy
NCT0169145645
Unlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fed Condition
Healthy
NCT0169146931
Unlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fasting Condition
Healthy
NCT0167170941
Unlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition
Healthy
NCT0167172243
Unlock trial analytics

Study Endpoints

Primary Endpoints

Area under curve(AUC)
Pre-dose (0.00) and 0.50, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hours post dose.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Montelukast Sodium Oral GranulesEXPERIMENTALMontelukast Sodium Oral Granules 4mg of Dr. Reddy's Laboratories Limited
SINGULAIRACTIVE_COMPARATOR(Montelukast sodium) Oral Granules 4mg of Merck Sharp \& Dohme Ltd., USA
Montelukast sodium tabletsEXPERIMENTALMontelukast sodium tablets 10mg of Dr. Reddy's Laboratories Limited

Interventions

NameTypeDescription
Montelukast sodiumDRUGMontelukast Sodium Oral Granules 4mg
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Subjects must fulfill the following criteria to be considered for inclusion into this study. * Healthy subjects within the age range of 18 to 50 years. * A body mass index between 18.5 to 24.9 Kg/m2 * Given written informed consent to participate in the study. * Absence of dise...

Countries:India
Unlock Eligibility Criteria