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Diflucan

Phase 1

Bioequivalence | Small molecule | Other |Ligand Pharmaceuticals Incorporated|Last Updated: Nov 30, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

Diflucan · 1 trial · 1 indication

Phase 1 1
NCT04038008Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting ConditionsBioequivalence
COMPLETED26 Analytics
PHASE1COMPLETED
Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions
Bioequivalence
NCT0403800826
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Study Endpoints

Primary Endpoints

Maximum observed concentration (Cmax) of fluconazole in plasma after administration of the test and the reference products
0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00 hours after each drug administration

Maximum observed concentration in plasma

AUC0-T of fluconazole in plasma after administration of the test and the reference products
0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00 hours after each drug administration

Cumulative area under the concentration time curve calculated from 0 to TLQC using the linear trapezoidal method, where TLQC represents time of last observed quantifiable concentration

AUC0-72 of fluconazole in plasma after administration of the test and the reference products (in case if AUC0-T is less than 80% of AUC0-∞ in more than 20% of the observations, truncated AUC0-72 will be used as primary endpoint instead of AUC0-T)
0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00 hours after each drug administration

Cumulative area under the concentration time curve calculated from 0 to 72 hours using the linear trapezoidal method. Nominal time will be used to estimate AUC0-72 using the NCA built-in tool in Phoenix® WinNonlin®. Any actual time that deviates by more than 1 minute from the 72-hour time point will be extrapolated/intrapolated as per Phoenix® WinNonlin®'s built-in formulas.

Secondary Endpoints

Tmax of fluconazole in plasma after administration of the test and the reference products
0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00 hours after each drug administration
TLQC of fluconazole in plasma after administration of the test and the reference products
0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00 hours after each drug administration
AUC0-∞ of fluconazole in plasma after administration of the test and the reference products
0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00 hours after each drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence ABOTHER13 subjects assigned to the sequence AB will receive a single 200 mg dose of test product Fluconazole (1 x 200 mg tablet), marked as A in the sequence, in Period 1 and a single 200 mg dose of reference product Diflucan® (1 x 200 mg hard capsule), marked as B in the sequence, in period 2. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a minimum of 10-hour overnight fast. The tablet or hard capsule must be swallowed whole and must not be chewed or broken.
Sequence BAOTHER13 subjects assigned to the sequence BA will receive a single 200 mg dose of reference product Diflucan® (1 x 200 mg hard capsule), marked as B in the sequence, in Period 1 and test product Fluconazole (1 x 200 mg tablet), marked as A in the sequence, in Period 2. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a minimum of 10-hour overnight fast. The tablet or hard capsule must be swallowed whole and must not be chewed or broken.

Interventions

NameTypeDescription
FluconazoleDRUGFluconazole is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 200 mg of fluconazole.
Diflucan®DRUGDiflucan® is manufactured by Fareva Amboise, France (MAH: PFIZER PHARMA PFE GmbH, Germany). Each hard capsule contains 200 mg of fluconazole.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy Caucasian adult male or female 4. If female, meets one of the following criteria: 1. Is of childbe...

Countries:Canada
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Frequently asked questions about Diflucan

What is Diflucan used for?

Diflucan is used for bioequivalence, specifically in a study comparing two formulations of fluconazole 200 mg in healthy adult subjects under fasting conditions. The study is a single-dose crossover comparative bioavailability study. It is not approved for any specific disease or condition.

Who makes Diflucan?

Diflucan is developed by Ligand Pharmaceuticals Incorporated, a company traded on the stock exchange under the ticker LGND. The company is conducting clinical trials for this drug, which is a small molecule.

What phase is Diflucan in?

Diflucan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for bioequivalence, and the trial is completed.

What clinical trials is Diflucan in?

Diflucan is associated with one clinical trial, NCT04038008, titled "Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions." This Phase 1 trial was completed in Canada, enrolling 26 healthy volunteers.

Is Diflucan the same as fluconazole?

Diflucan is a brand name for fluconazole, an antifungal medication. The clinical trial for Diflucan compares two formulations of fluconazole 200 mg, indicating that Diflucan is a formulation of fluconazole.