Test drug - Bioequivalence | Phase 1 | Pfizer, Inc. | BiopharmaWatch

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Test drug

Phase 1

Bioequivalence | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 16, 2021

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker

Total Trials1

Total Enrollment28

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT03821480	Diflucan Bioequivalence Study For Transferring The Manufacture	PHASE1	COMPLETED	28	—	—	Jan 28, 2019	Mar 6, 2019	Jul 16, 2021	1	South Korea

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Study Endpoints

Primary Endpoints

1.Area Under Curve [AUC]last of fluconazole in Whole blood

At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

Area Under Curve(AUC) will be evaluated with Winnonlin analysis(Linear trapezoidal linear interpolation).

2.Maximum Plasma Concentration [Cmax] of fluconazole in Whole blood

At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

Plasma concentrations of fluconazole will be assayed by a validated LC- MS/MS method.

Secondary Endpoints

1.AUCinf

At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

2.AUCt/AUCinf

At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

3.t½

At pre-dose (immediately prior to dosing) and 0.16, 0.33, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24, 48, 72 and 96 hours postdose.

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelCROSSOVER

PurposeBASIC_SCIENCE

Treatment Arms

Arm	Type	Description
Fluconazole 50 mg, Manufacturer: Amboise	EXPERIMENTAL	Test drug
Fluconazole 50mg, Manufacturer:West Ryde	ACTIVE_COMPARATOR	Reference drug

Interventions

Name	Type	Description
Test drug	DRUG	Fluconazole capsule 50 mg Manufacturer: West Ryde
Reference drug	DRUG	Fluconazole capsule 50 mg Manufacturer: Amboise

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Eligibility Criteria

Age Range19 Years — 55 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria * Healthy male and subjects who are between the ages of 19 and 55 years. * Female subjects who are found not to be pregnant in physical examinations * BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * Evidence of a personally signed and dated informed consent...

Countries:South Korea

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