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Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
The First Hospital of Jilin University/Phase I Clinical Trials Unit
Changchun, Jilin, 130021 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
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Subjects must meet all of the following inclusion criteria to be eligible for enrollment in
the study:

1. Healthy Chinese male and female subjects, between the ages of 18 and 45 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. BMI of 18 to 28 kg/m2; 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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Subjects with any of the following characteristics/conditions will not be included in the
study:

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, history of drug abuse within the past 5 years.

4. History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 100 mL of
wine or 285 mL of beer or 25 mL of hard liquor) within 3 months of Screening.

5. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day within 3 months prior to Screening.

6. Treatment with an investigational drug within 3 months preceding the first dose of
investigational product.

7. Screening supine 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, dietary supplements and herbal medicines
within 14 days prior to Screening. As an exception, acetaminophen/paracetamol may be
used at doses of ?1 g/day. Limited use of nonprescription medications that are not
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. Taking any medicinal
product that changes the activity of hepatic enzymes within 28 days prior to
Screening, such as a strong CYP3A4 inducer (eg, St. John's Wort).

12. Blood donation (excluding plasma donations) or loss of blood of approximately 450 mL
or more within 3 months prior to Screening.

13. History of hypersensitivity to azithromycin or any components of its formulation.

14. Use of special diet (including dragon fruit, mango, citrus, etc.), strenuous
activities or other factors that may affect the disposition of the study medication
within 14 days prior to Screening.

15. Use of chocolate, food or beverages containing caffeine or xanthine within 48 hours
prior to dosing.

16. Use of products containing alcohol within 48 hours prior to dosing.

17. Intolerance of the standard high fat breakfast, which is only applicable to the
subjects participating in Group 2 (fed condition).

18. History of HIV, hepatitis B, or hepatitis C; positive testing for HIV, HepBsAg,
HepBcAb, HCVAb, or TPPA.

19. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section.

20. 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.

21. 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.

NCT03353480
Pfizer
Completed
Bioequivalence (BE) Study Comparing Azithromycin 250 mg Tablet Manufactured in China and in the United States

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