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Isotretinoin

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 27, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials4
Total Enrollment163

FDA Designations

No designations recorded

Clinical trial landscape

Isotretinoin · 4 trials · 1 indication

Phase 1 4
NCT01888224Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed ConditionHealthy
COMPLETED61 Analytics
NCT01888341Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting ConditionHealthy
COMPLETED41 Analytics
NCT01888289Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting ConditionHealthy
COMPLETED35 Analytics
NCT01888328Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed ConditionHealthy
COMPLETED26 Analytics
PHASE1COMPLETED
Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition
Healthy
NCT0188822461
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PHASE1COMPLETED
Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition
Healthy
NCT0188834141
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PHASE1COMPLETED
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
Healthy
NCT0188828935
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PHASE1COMPLETED
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
Healthy
NCT0188832826
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Study Endpoints

Primary Endpoints

Area under curve (AUC)
Pre-dose (0) and 0.5, 1,1.5,2,2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8,10,12,16,20,24, 36, 48,72 and 96 hrs
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Isotretinoin capsules, 40 mgEXPERIMENTALIsotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd
AMNESTEEMACTIVE_COMPARATORAMNESTEEM 40 mg of Mylan Pharmaceuticals Inc
Isotretinoin capsules, 20 mgEXPERIMENTALIsotretinoin Capsules, 20 mg of Dr.Reddy's Laboratories Ltd
ACCUTANEACTIVE_COMPARATORACCUTANE 20 mg of Roche Laboratories Inc

Interventions

NameTypeDescription
IsotretinoinDRUGIsotretinoin Capsules,40 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult human male volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India. * Having a Body Mass Index (BMI) between 18.5-27.5 (both inclusive), calculated as weight in kg / height in meter2. * Not having any...

Countries:IndiaUnited States
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Frequently asked questions about Isotretinoin

What is Isotretinoin used for?

Isotretinoin is a small molecule being studied in healthy volunteers in Phase 1 clinical trials. The trials are bioavailability and bioequivalence studies of Isotretinoin capsules at 40 mg and 20 mg doses, conducted under fed and fasting conditions.

Who makes Isotretinoin?

Isotretinoin is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting Phase 1 clinical trials to evaluate the bioavailability and bioequivalence of Isotretinoin capsules.

What phase is Isotretinoin in?

Isotretinoin is in Phase 1 clinical development. All four clinical trials associated with Isotretinoin are Phase 1 studies and have been completed. The trials enrolled a total of 163 healthy male volunteers.

What clinical trials is Isotretinoin in?

Isotretinoin has been studied in four completed Phase 1 clinical trials. These include NCT01888224, a bioavailability study of 40 mg capsules under fed conditions in India; NCT01888289, a bioequivalence study of 40 mg capsules under fasting conditions in the United States; NCT01888328, a bioequivalence study of 40 mg capsules under fed conditions in the United States; and NCT01888341, a bioequivalence study of 20 mg capsules under fasting conditions in the United States.

Is Isotretinoin FDA approved?

Isotretinoin is an investigational drug currently in Phase 1 clinical development. The available clinical trials are bioavailability and bioequivalence studies conducted in healthy volunteers, and the drug has not been reported as approved by the FDA.