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Cymbalta

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

Cymbalta · 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
Healthy
NCT0229134176
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PHASE1COMPLETED
Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
Healthy
NCT0229136776
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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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Frequently asked questions about Cymbalta

What is Cymbalta?

Cymbalta is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers for bioavailability purposes, with two completed trials.

What is Cymbalta used for?

Cymbalta is being studied in healthy volunteers as part of bioavailability studies. The completed trials assessed the drug under fed and fasting conditions. The drug is not approved for any specific indication and remains investigational.

Who makes Cymbalta?

Cymbalta is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange with the ticker RDY. The company is conducting Phase 1 clinical trials for this drug.

What phase is Cymbalta in?

Cymbalta is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are no active trials currently. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Cymbalta in?

Cymbalta has two completed Phase 1 trials: NCT02291341, a bioavailability study under fed conditions, and NCT02291367, a bioavailability study under fasting conditions. Both trials enrolled 76 healthy volunteers each in India.

Is Cymbalta the same as duloxetine?

Cymbalta is the brand name for duloxetine, as indicated by the trial titles which reference duloxetine delayed-release capsules. The drug is being studied in healthy volunteers for bioavailability, not for any therapeutic indication.