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Eszopiclone

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Dec 23, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

Eszopiclone · 2 trials · 1 indication

Phase 1 2
NCT02322658Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed ConditionsHealthy
COMPLETED46 Analytics
NCT02322645Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting ConditionsHealthy
COMPLETED46 Analytics
PHASE1COMPLETED
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions
Healthy
NCT0232265846
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PHASE1COMPLETED
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fasting Conditions
Healthy
NCT0232264546
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Study Endpoints

Primary Endpoints

Area under curve
0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0 and 48.0 hours post dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Eszopiclone TabletsEXPERIMENTALEszopiclone Tablets 3 mg of Dr. Reddy's Laboratories Limited
LunestaACTIVE_COMPARATORLunesta Tablets 3 mg of Sepracor Inc.

Interventions

NameTypeDescription
Eszopiclone Tablets 3 mgDRUG -
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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 Eszopiclone

What is Eszopiclone?

Eszopiclone is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development, with studies conducted in healthy volunteers. The drug is being investigated for its effects in healthy individuals, and it is not yet approved for any medical condition.

What is Eszopiclone used for?

Eszopiclone is being studied for use in healthy volunteers, as part of bioequivalence studies. These trials are designed to compare the drug's absorption and effects under fasting and fed conditions. It is not currently approved for any specific medical indication.

Who makes Eszopiclone?

Eszopiclone is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting Phase 1 clinical trials to evaluate the drug's bioequivalence in healthy subjects.

What phase is Eszopiclone in?

Eszopiclone is in Phase 1 clinical development. Two Phase 1 bioequivalence studies have been completed, with a total of 92 participants enrolled. The drug is still investigational and has not received FDA approval for any use.

What clinical trials is Eszopiclone in?

Eszopiclone has two completed Phase 1 clinical trials: NCT02322645, a bioequivalence study of 3 mg tablets under fasting conditions, and NCT02322658, a similar study under fed conditions. Both trials enrolled 46 healthy volunteers each and were conducted in India.

Is Eszopiclone the same as Lunesta?

Eszopiclone is the active ingredient in the brand-name medication Lunesta, which is used to treat insomnia. However, the drug being developed by Dr. Reddy's Laboratories is an investigational version, and it is not yet approved by regulatory authorities.