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Fluconazole

Phase 4

Pharmacology, Clinical | Small molecule | Other |Bayer AG|Trials Updated: Apr 29, 2019

Fluconazole development status

Highest phase Phase 4 (NCT02180828)
Phase scored for BAYRYPhase 1
Registered trials 79 across 27 sponsors since Feb 2000

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Fluconazole clinical trials

Fluconazole · 1 trial · 1 indication

Phase 1 1
NCT03929861Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole FormulationsPharmacology, Clinical
COMPLETED26 Analytics
PHASE1COMPLETED
Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations
Pharmacology, ClinicalUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax
Pre-dose and up to 72 hours post-dose

Concentration maximum

AUC0-tlast
Pre-dose and up to 72 hours post-dose

Area under the plasma concentration time curve from time 0 to the last data point above the lower limit of quantification

Secondary Endpoints

Number of participants with Adverse Events as a Measure of safety and tolerability
Up to 7 weeks
tmax
Pre-dose and up to 72 hours post-dose
t½λz
Pre-dose and up to 72 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Fluconazole, period 1EXPERIMENTALSubjects were randomized to receive a single dose of 150 mg fluconazole on Day 1 of period 1 after an overnight fast of at least 10 hours
Fluconazole, period 2EXPERIMENTALSubjects were randomized to receive a single dose of 150 mg fluconazole on Day 1 of period 2 after an overnight fast of at least 10 hours

Interventions

NameTypeDescription
Fluconazole (BAYT006267) 150 mg capsulesDRUGFluconazole 150 mg
Fluconazole 150 mg capsules (DiflucanTM)DRUGFluconazole 150 mg
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males in the age between 18 and 50 years * Subjects with a body weight of at least 50 kg and a BMI between 18.5 and 30.0 kg/m2 * Subjects had to be willing to use an acceptable method of contraception (double barrier) during the study and 2 weeks after the end of the s...

Countries:Germany
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Frequently asked questions about Fluconazole

What is Fluconazole?

Fluconazole is a small molecule drug developed by Bayer AG under the code BAYT006267, formulated as 150 mg capsules. It has been studied in a Phase 1 bioequivalence trial in Germany. The trial enrolled 26 healthy male volunteers and was completed. Fluconazole is also known by its developmental code BAYT006267.

Who makes Fluconazole?

Fluconazole is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. The drug is also identified by the developmental code BAYT006267. Bayer AG conducted a Phase 1 bioequivalence trial of two different fluconazole formulations to demonstrate equal blood concentrations.

What phase is Fluconazole in?

Fluconazole is in Phase 1 clinical development. A single Phase 1 bioequivalence trial has been completed, and no active trials are ongoing. The trial was conducted in Germany and enrolled 26 healthy male volunteers. Fluconazole is investigational and has not been approved by the FDA for any indication.

What clinical trials is Fluconazole in?

Fluconazole has been studied in one completed Phase 1 clinical trial, NCT03929861, titled "Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations." The trial was conducted in Germany, enrolled 26 healthy male volunteers, and used a randomized, controlled design. No active trials are currently listed.

Is Fluconazole the same as BAYT006267?

Yes, Fluconazole is also known as BAYT006267. The 150 mg capsules are identified by the developmental code BAYT006267. This alternative name may appear in regulatory filings, clinical trial registries, or scientific literature. Both names refer to the same small molecule drug developed by Bayer AG.