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Diflucan Bioequivalence Study For Transferring The Manufacture

Last updated on October 14, 2019

FOR MORE INFORMATION
Study Location
Chungnam National University Hospital, Clinical Trials Center
Daejeon, , 301-721 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bioequivalence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT03821480
Pfizer
Completed
Diflucan Bioequivalence Study For Transferring The Manufacture

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Descriptive Information
Brief Title  ICMJE Diflucan Bioequivalence Study For Transferring The Manufacture
Official Title  ICMJE AN OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER PIVOTAL BIOEQUIVALENCE STUDY OF FLUCONAZOLE CAPSULE 50 MG IN HEALTHY ADULT SUBJECTS
Brief SummaryThis 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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

Condition  ICMJE Bioequivalence
Intervention  ICMJE
  • Drug: Test drug
    Fluconazole capsule 50 mg Manufacturer: West Ryde
    Other Name: Fluconazole capsule 50mg
  • Drug: Reference drug
    Fluconazole capsule 50 mg Manufacturer: Amboise
    Other Name: Fluconazole capsule 50mg
Study Arms  ICMJE
  • Experimental: Fluconazole 50 mg, Manufacturer: Amboise
    Test drug
    Intervention: Drug: Test drug
  • Active Comparator: Fluconazole 50mg, Manufacturer:West Ryde
    Reference drug
    Intervention: Drug: Reference drug
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2019)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 6, 2019
Actual Primary Completion DateMarch 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821480
Other Study ID Numbers  ICMJE A0561026
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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