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Terbinafine

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Terbinafine · 1 trial · 1 indication

Phase 1 1
NCT01772212Bioequivalence Study for Terbinafine 250 mgMycoses
COMPLETED30 Analytics
PHASE1COMPLETED
Bioequivalence Study for Terbinafine 250 mg
MycosesUnlock trial analytics

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

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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
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Eligibility Criteria

Age Range18 Years to 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...

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Frequently asked questions about Terbinafine

What is Terbinafine used for?

Terbinafine is a small molecule drug used for the treatment of mycoses, which are fungal infections. It is being developed by GSK plc. The drug is currently in Phase 1 clinical development, meaning it is investigational and has not yet been approved for use.

Who makes Terbinafine?

Terbinafine is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for the treatment of mycoses, a type of fungal infection.

What phase is Terbinafine in?

Terbinafine is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of mycoses. The drug has not yet been approved by regulatory authorities, and further clinical trials are needed to evaluate its safety and efficacy.

What clinical trials is Terbinafine in?

Terbinafine has been studied in a Phase 1 clinical trial with the identifier NCT01772212. This trial was a bioequivalence study for Terbinafine 250 mg, which enrolled 30 participants with mycoses. The trial was completed and included healthy volunteers.

Is Terbinafine the same as any other drug?

Terbinafine is a drug being developed by GSK plc for the treatment of mycoses. It is a small molecule that is currently in Phase 1 clinical development. No alternative names for this drug have been disclosed.