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Diflucan Bioequivalence Study For Transferring The Manufacture

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ClinicalTrials.gov Identifier: NCT03821480
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Test drug Drug: Reference drug Phase 1

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: open-label, randomized, single dose, 2-treatment, 2-period crossover study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER PIVOTAL BIOEQUIVALENCE STUDY OF FLUCONAZOLE CAPSULE 50 MG IN HEALTHY ADULT SUBJECTS
Actual Study Start Date : January 28, 2019
Actual Primary Completion Date : March 6, 2019
Estimated Study Completion Date : April 6, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole

Arm Intervention/treatment
Experimental: Fluconazole 50 mg, Manufacturer: Amboise
Test drug
Drug: Test drug
Fluconazole capsule 50 mg Manufacturer: West Ryde
Other Name: Fluconazole capsule 50mg

Active Comparator: Fluconazole 50mg, Manufacturer:West Ryde
Reference drug
Drug: Reference drug
Fluconazole capsule 50 mg Manufacturer: Amboise
Other Name: Fluconazole capsule 50mg




Primary Outcome Measures :
  1. 1.Area Under Curve [AUC]last of fluconazole in Whole blood [ Time Frame: 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. 2.Maximum Plasma Concentration [Cmax] of fluconazole in Whole blood [ Time Frame: 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 Outcome Measures :
  1. 1.AUCinf [ Time Frame: 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. 2.AUCt/AUCinf [ Time Frame: 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. 3.t½ [ Time Frame: 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. 4.Tmax [ Time Frame: 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



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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 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.

Exclusion Criteria

  • 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).
  • Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
  • Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Other acute or chronic medical or psychiatric condition
  • Subjects with known sensitivity to the drug or any of the insert ingredients or to related azole compounds.
  • Subjects with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821480


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Korea, Republic of
Chungnam National University Hospital, Clinical Trials Center Recruiting
Daejeon, Korea, Republic of, 301-721
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03821480     History of Changes
Other Study ID Numbers: A0561026
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Fluconazole

Additional relevant MeSH terms:
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Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors