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Finasteride

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Dec 21, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Finasteride · 4 trials · 1 indication

Phase 1 4
NCT01264289Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting ConditionsHealthy
COMPLETED26 Analytics
NCT01264302Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting ConditionsHealthy
COMPLETED26 Analytics
NCT01133444Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting ConditionHealthy
COMPLETED24 Analytics
NCT01133457Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed ConditionHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Finasteride tablets 5 mgEXPERIMENTALFinasteride tablets 5 mg of Dr.Reddy's Laboratories Limited
Proscar 5 mg TabletsACTIVE_COMPARATORProscar 5 mg Tablets of Merck \& Co. Inc
FinasterideEXPERIMENTALFinasteride tablets 1 mg of Dr. Reddy's
PropeciaACTIVE_COMPARATORPropecia 1 mgTablets of Merck \& Co.,

Interventions

NameTypeDescription
FinasterideDRUGFinasteride Tablets 5 mg
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Males, 18-65 years of age (inclusive). 2. A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures. 3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening...

Countries:United StatesCanada
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Frequently asked questions about Finasteride

What is Finasteride used for?

Finasteride is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd for use in healthy volunteers. It is currently in Phase 1 clinical trials, specifically for bioequivalence studies of its tablet formulations. The drug is being studied in both 1 mg and 5 mg tablet strengths.

Who makes Finasteride?

Finasteride is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company traded under the ticker symbol RDY. The company is conducting Phase 1 clinical trials to evaluate the bioequivalence of its finasteride tablet formulations in healthy male volunteers.

What phase is Finasteride in?

Finasteride is in Phase 1 clinical development. All four clinical trials for this drug have been completed, with none currently active. These Phase 1 studies are bioequivalence trials conducted in healthy male volunteers aged 18 years and older.

What clinical trials is Finasteride in?

Finasteride has been studied in four completed Phase 1 clinical trials. These include NCT01133444 and NCT01133457, which evaluated 1 mg tablets under fasting and fed conditions in Canada, and NCT01264289 and NCT01264302, which assessed 5 mg tablets under fasting and non-fasting conditions in the United States.

Is Finasteride FDA approved?

Finasteride is an investigational drug currently in Phase 1 clinical development. It has not been approved by the FDA. The ongoing studies are bioequivalence trials conducted in healthy volunteers, which are typically part of the process for generic drug development.