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Terbinafine ,

Phase 1

Fasting | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 11, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01286688Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fasting ConditionsPHASE1 COMPLETED 36Jan 1, 2002Mar 1, 2002Jan 11, 20121 Canada
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Study Endpoints
Primary Endpoints
Bioequivalence study based on Cmax parameter
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Terbinafine HydrochlorideEXPERIMENTALTerbinafine Hydrochloride Tablets, 250 mg of Dr.Reddy's Laboratories Limited
Lamisil® 250 mg TabletsACTIVE_COMPARATORLamisil® 250 mg Tablets of Novartis
Interventions
NameTypeDescription
Terbinafine Hydrochloride Tablets, 250 mgDRUGTerbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Web site, Anapharm volunteers' data base). ---Subjects must meet all of the following criteria in order ...

Countries:Canada
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