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Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France

Last updated on July 2, 2019

FOR MORE INFORMATION
Study Location
Wuxi People's Hospital
Wuxi, Jiangsu, 214023 China
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
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Healthy Chinese male and female subjects, between the ages of 18 and 55 years,
inclusive. Healthy is defined as no clinically relevant abnormalities identified by a
detailed medical history, full physical examination, including blood pressure (BP) and
pulse rate (PR) measurement, 12-lead ECG, or clinical laboratory tests.

2. Body Mass Index (BMI) of 18 to 28 kg/m**2, inclusive; and a total body weight >=50 kg
for males and >= 45 kg for females.

3. Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.

4. Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

5. Subjects must be of Chinese ethnicity (individuals currently residing in mainland
China who were born in China and have both parents of Chinese descent)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

2. Any condition possibly affecting drug absorption (eg, gastrectomy).

3. A positive urine drug screen.

4. History of regular alcohol consumption exceeding 7 drinks/week for female subjects or
14 drinks/week for male subjects (1 drink = 150 mL of wine or 360 mL of beer or (45 mL
of hard liquor) within 6 months of Screening.

5. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day within 3 months of Screening; a positive urine nicotine test.

6. Treatment with an investigational drug (which has not been approved for registration)
within 30 days preceding the first dose of investigational product. If the
investigational drug has a long elimination half-life, the washout period will be
longer with a recommendation of five elimination half-lives.

7. Screening BP >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5
minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP
should be repeated 2 more times and the average of the 3 BP values should be used to
determine the subject's eligibility.

8. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or
a QRS complex >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG
should be repeated 2 more times and the average of the 3 QTc or QRS values should be
used to determine the subject's eligibility.

9. Female subjects of childbearing potential and fertile male subjects who are unwilling
or unable to use a highly effective method of contraception as outlined in this
protocol for the duration of the study and for at least 28 days after the last dose of
investigational product.

10. Female subjects who are breastfeeding or with positive pregnancy test at Screening and
during the study period.

11. Use of prescription or nonprescription drugs and dietary supplements within 7 days
prior to the first dose of investigational product. If the concomitant medication has
a long elimination half-life, the washout period will be longer with a recommendation
of five elimination half-lives. As an exception, acetaminophen/paracetamol may be used
at doses of believed to affect subject safety or the overall results of the study may be permitted
on a case by case basis following approval by the sponsor.

12. Blood donation (excluding plasma donations) of approximately 400 mL or more within 60
days prior to dosing.

13. History of sensitivity to heparin or heparin induced thrombocytopenia.

14. History of hypersensitivity to fluconazole or any components of its formulation.

15. History of hepatitis B or hepatitis C; positive testing for hepatitis B surface
antigen (HepBsAg), hepatitis B core antibody (HepBcAb), hepatitis C antibody (HCVAb),
treponema pallidum antibody (TPPA) or human immunodeficiency virus (HIV) antibody.

16. Unwilling or unable to comply with the criteria in the Lifestyle Guidelines described
in this protocol.

17. 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.

18. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.

NCT03621072
Pfizer
Recruiting
Bioequivalence (BE) Study Comparing Fluconazole 150mg Capsule Manufactured in China and in France

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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