Recent Updates
Recently added Catalysts

Terbinafine

Phase 1

Mycoses | Small molecule | Other |GSK plc|Last Updated: Jun 22, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01772212Bioequivalence Study for Terbinafine 250 mgPHASE1 COMPLETED 30 — — Feb 24, 2011Mar 15, 2011Jun 22, 2017 - —
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Peak Plasma Concentration (CMAX) of drug terbinafine
0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours post dose

pharmacokinetics

Area under the plasma concentration versus time curve (AUC) of drug terbinafine
0.0, 0.33, 0.66, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 3.5, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours post dose

pharmacokinetics

Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
A(test)/B(reference)EXPERIMENTALInitial administration of test and crossover to reference
B(reference)/A(test)EXPERIMENTALInitial administration of reference and crossover to test
Interventions
NameTypeDescription
Terbinafine 250 mgDRUGTest product
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: Inclusion Criteria: Males 18-50 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90...

Unlock Eligibility Criteria