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Label indication CYMBALTA ® is indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults CYMBALTA ® is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the… FDA label
Also known as Cymbalta
Duloxetine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Duloxetine Delayed-Release Capsules, 60 mg | EXPERIMENTAL | Duloxetine Delayed-Release Capsules, 60 mg of Dr. Reddys Laboratories Limited |
| Cymbalta | ACTIVE_COMPARATOR | Cymbalta® 60 mg capsule of Eli Lilly and Company |
| Name | Type | Description |
|---|---|---|
| Duloxetine | DRUG | Duloxetine Delayed-Release Capsules 60 mg |
| Cymbalta® | DRUG | 60 mg capsule of Eli Lilly and Company |
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...
Duloxetine is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed. Duloxetine is a generic-name medication, and Dr. Reddy's Laboratories is listed under the ticker RDY.
Duloxetine targets SLC6A2 and SLC6A4. It acts as an inhibitor of these targets. SLC6A2 and SLC6A4 are transporter proteins involved in neurotransmitter reuptake. By inhibiting them, Duloxetine modulates neurotransmitter signaling. This mechanism underlies its classification as a small molecule inhibitor developed by Dr. Reddy's Laboratories.
Duloxetine is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is listed as the developer of this small molecule drug candidate. Dr. Reddy's Laboratories is conducting clinical development of Duloxetine, with two completed Phase 1 trials registered to date.
Duloxetine is in Phase 1 clinical development. It is an investigational drug and is not approved. Two Phase 1 trials have been completed, and no active trials are currently listed. The completed trials enrolled a total of 152 participants and evaluated bioavailability under fasting and fed conditions.
Two completed Phase 1 trials of Duloxetine are registered: NCT02291367, a bioavailability study of delayed-release capsules under fasting conditions, and NCT02291341, a bioavailability study under fed conditions. Both enrolled 76 healthy volunteers in India, were randomized and active-controlled, with participants aged 18 years and older.
Duloxetine is the generic name for the drug substance. Dr. Reddy's Laboratories Ltd is developing this version under the Duloxetine name. The two registered trials, NCT02291367 and NCT02291341, evaluate delayed-release capsules of 60 mg under fasting and fed conditions, consistent with a generic bioavailability program.