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Diflucan Bioequivalence Study For Transferring The Manufacture

Last updated on March 18, 2019

Study Location
Chungnam National University Hospital, Clinical Trials Center
Daejeon, , 301-721 Korea, Republic of
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
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.
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- 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.
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- 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.

Diflucan Bioequivalence Study For Transferring The Manufacture


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