Diflucan Bioequivalence Study For Transferring The Manufacture

NCT03821480 | Completed Phase 1

• 1 other identifier: A0561026
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioequivalence

Keywords

Fluconazole

Outcome Measures

Primary Outcomes (2)

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

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

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

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

  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.

Secondary Outcomes (4)

• 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.

• 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.

Study Arms (2)

Fluconazole 50 mg, Manufacturer: Amboise

EXPERIMENTAL

Test drug

Drug: Test drug

Fluconazole 50mg, Manufacturer:West Ryde

ACTIVE COMPARATOR

Reference drug

Drug: Reference drug

Interventions

Test drug DRUG

Fluconazole capsule 50 mg Manufacturer: West Ryde

Also known as: Fluconazole capsule 50mg

Fluconazole 50 mg, Manufacturer: Amboise

Reference drug DRUG

Fluconazole capsule 50 mg Manufacturer: Amboise

Also known as: Fluconazole capsule 50mg

Fluconazole 50mg, Manufacturer:West Ryde

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with all study procedures.

You may not qualify if:

• Evidence or history of clinically significant disease
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug test.
• History of regular alcohol consumption exceeding standard for the study
• Treatment with an investigational drug within 3 months or 5 half-lives preceding the first dose of investigational product (whichever is longer).
• Screening seated BP 140 mm Hg (systolic) or 90 mm Hg (diastolic) and over
• Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval over 450 msec or a QRS interval over 120 msec.
• Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, when assessed by the study-specific laboratory and confirmed by a single repeat test:
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level over 2 upper limit of normal (ULN); Total bilirubin level 2.0 mg/mL and over; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is same or under ULN.
• Pregnant female subjects, breastfeeding female subjects, male subjects, who are fertile enough and female subjects of childbearing potential for at least 28 days after the last dose of investigational product.
• Use of prescription or nonprescription drugs and dietary supplements within 10 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
• Use of any drugs known to significantly induce (e.g., barbiturates) or inhibit drug- metabolizing enzymes or excessive alcohol consumption within one month prior to the time of screening.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• History of hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), human immunodeficiency virus (HIV) antigen or antibody, and/or syphilis (RPR, Rapid Plasma Reagin test).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Chungnam National University Hospital, Clinical Trials Center

Daejeon, 35015, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Drug Evaluation; Fluconazole

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, randomized, single dose, 2-treatment, 2-period crossover study

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 29, 2019
• Study Start: January 28, 2019
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)