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Febuxostat

Phase 1

Bioequivalence | Small molecule | Other |Ligand Pharmaceuticals Incorporated|Last Updated: Jul 8, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

Febuxostat · 1 trial · 1 indication

Phase 1 1
NCT03918551Bioequivalence Study of Two Formulations of Febuxostat 120 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting ConditionsBioequivalence
COMPLETED50 Analytics
PHASE1COMPLETED
Bioequivalence Study of Two Formulations of Febuxostat 120 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions
Bioequivalence
NCT0391855150
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Study Endpoints

Primary Endpoints

Cmax of febuxostat in plasma after administration of the test and the reference products
Time points 0.00 (prior to each drug administration) and 0.25, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 18.00, 24.00, 36.00 hours after each drug administration

Maximum observed concentration in plasma

AUC0-T of febuxostat in plasma after administration of the test and the reference products
Time points 0.00 (prior to each drug administration) and 0.25, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 18.00, 24.00, 36.00 hours after each drug administration

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

Secondary Endpoints

Tmax of febuxostat in plasma after administration of the test and the reference products
Time points 0.00 (prior to each drug administration) and 0.25, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 18.00, 24.00, 36.00 hours after each drug administration
TLQC of febuxostat in plasma after administration of the test and the reference products
Time points 0.00 (prior to each drug administration) and 0.25, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 18.00, 24.00, 36.00 hours after each drug administration
AUC0-∞ of febuxostat in plasma after administration of the test and the reference products
Time points 0.00 (prior to each drug administration) and 0.25, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 18.00, 24.00, 36.00 hours after each drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence ABOTHER25 subjects assigned to the sequence AB will receive a single 120 mg dose of the test product Febuxostat (1 x 120 mg film-coated tablet), marked as A in the sequence, in Period 1 and a single 120 mg dose of the reference product Adenuric (1 x 120 mg film-coated tablet), 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 must be swallowed whole and must not be chewed or broken.
Sequence BAOTHER25 subjects assigned to the sequence BA will receive a single 120 mg dose of the reference product Adenuric (1 x 120 mg film-coated tablet), marked as B in the sequence, in Period 1 and a single 120 mg dose of the test product Febuxostat (1 x 120 mg film-coated 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 must be swallowed whole and must not be chewed or broken.

Interventions

NameTypeDescription
FebuxostatDRUGFebuxostat is manufactured by Pharmtechnology LLC, Republic of Belarus. Each film-coated tablet contains 120 mg of febuxostat.
AdenuricDRUGAdenuric is manufactured by Menarini - Von Heyden GmbH, Germany (MAH: Menarini International Operations Luxembourg S.A., Luxembourg). Each film-coated tablet contains 120 mg of febuxostat.
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Eligibility Criteria

Age Range18 Years to N/A
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 male or female adult volunteer 4. A female volunteer meeting one of the following criteria: 1. Par...

Countries:Canada
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Frequently asked questions about Febuxostat

What is Febuxostat used for?

Febuxostat is a small molecule being studied for bioequivalence. It is the subject of a Phase 1 clinical trial comparing two formulations of febuxostat 120 mg film-coated tablets in healthy adult volunteers under fasting conditions. The drug is currently in clinical development and is not approved.

Who makes Febuxostat?

Febuxostat is being developed by Ligand Pharmaceuticals Incorporated, which trades on the stock exchange under the ticker LGND. The company is conducting clinical research on this small molecule drug for bioequivalence purposes.

What phase is Febuxostat in?

Febuxostat is in Phase 1 clinical development. A Phase 1 bioequivalence study has been completed, involving 50 healthy adult volunteers. The drug is investigational and has not been approved for marketing.

What clinical trials is Febuxostat in?

Febuxostat has one completed clinical trial registered as NCT03918551. This Phase 1 study evaluated the bioequivalence of two formulations of febuxostat 120 mg film-coated tablets after a single oral dose in healthy volunteers under fasting conditions. The trial was conducted in Canada.

Is Febuxostat the same as other drugs?

Febuxostat is a small molecule drug being investigated for bioequivalence. The clinical trial compares two formulations of febuxostat 120 mg film-coated tablets, indicating the drug is being studied in different tablet formulations. No other alternative names are known.