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Duloxetine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Nov 14, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

Duloxetine · 2 trials · 1 indication

Phase 1 2
NCT02291341Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed ConditionHealthy
COMPLETED76 Analytics
NCT02291367Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting ConditionHealthy
COMPLETED76 Analytics
PHASE1COMPLETED
Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under curve (AUC)
1.0, 2.0,3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 11.0, 12.0, 24.0, 36.0, 48.0,60.0 and 72.0 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Duloxetine Delayed-Release Capsules, 60 mgEXPERIMENTALDuloxetine Delayed-Release Capsules, 60 mg of Dr. Reddys Laboratories Limited
CymbaltaACTIVE_COMPARATORCymbalta® 60 mg capsule of Eli Lilly and Company

Interventions

NameTypeDescription
DuloxetineDRUGDuloxetine Delayed-Release Capsules 60 mg
Cymbalta®DRUG60 mg capsule of Eli Lilly and Company
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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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