Diflucan Bioequivalence Study For Transferring The Manufacture

Phase 1

Completed

• Conditions: Bioequivalence
• Interventions: Drug: Reference drug; Drug: Test drug

• Registration Number: NCT03821480
• Lead Sponsor: Pfizer

Brief Summary

This study is to assess the bioequivalence between fluconazole 50mg capsules from two different manufacturers. This is a open-label, randomized, single dose, 2-treatment, 2-period crossover study in healthy Korean male and female subjects aged 19-55, to assess the bioequivalence after taking study drugs.

Detailed Description

Twenty-eight (28) healthy subjects will be enrolled into the study. Screening evaluation will occur within 28 days prior to the first dose of study medication.

Subjects will be randomized to the following treatments:

* Treatment A: Fluconazole capsule, 1 x 50 mg, Diflucan, West Ryde (REFERENCE)

* Treatment B: Fluconazole capsule, 1 x 50 mg, Diflucan, Amboise (TEST)

Study Timeline

• Study Start: 2019-01-28
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Primary Completion: 2019-03-06
• Study Completion: 2019-03-06
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fluconazole 50mg, Manufacturer:West Ryde	Reference drug	Reference drug
Fluconazole 50 mg, Manufacturer: Amboise	Test drug	Test drug

Primary Outcome Measures

Name	Time	Method
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.
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).

Secondary Outcome Measures

Name	Time	Method
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.	Area under the plasma concentration-time profile from time zero extrapolated to infinite time
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.	AUCt: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) AUCinf: Area under the plasma concentration-time profile from time zero extrapolated to infinite time
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.	Half-life time of fluconazole
4.Tmax	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.	Time of Max concentration of fluconazole

Trial Locations

Locations (1)

Chungnam National University Hospital, Clinical Trials Center; 🇰🇷 Daejeon, Korea, Republic of