Status:
UNKNOWN
Influence of Ethnicity and ABCB1 Gene Polymorphism on the Pharmacokinetics of Azithromycin in Healthy Bangladeshi Volunteers
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions:
Comparative Bioavailability Study
Eligibility:
All Genders
20-25 years
Phase:
PHASE1
Brief Summary
It is well recognized that different patients respond in different ways to the same medication. These differences are often greater among members of a population than they are within the same person a...
Detailed Description
Individual variation in drug response is a major problem in clinical practices and drug development which ranges from therapeutic failure to adverse drug reaction as drug reaction in multidrug therapy...
Eligibility Criteria
Inclusion
- Healthy Bangladeshi male and female subjects, between the ages of 20 and 25 years. 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, routine laboratory tests (Blood chemistry, hematology and urine analysis).
- 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 must be the residence of Chittagong Hill Tracts by birth.
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Exclusion
- Liver cirrhosis.
- Chronic renal failure. .
- History of gastrectomy.
- History of drug abuse within the past 5 years.
- Treatment with an investigational drug within 3 months preceding the first dose of investigational product.
- 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.
- 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.
- Female subjects who are breastfeeding or with positive pregnancy test at Screening and during the study period.
- Use of prescription or nonprescription drugs, dietary supplements and herbal medicines within 14 days prior to Screening.
- Blood donation (excluding plasma donations) or loss of blood of approximately 450 mL or more within 3 months prior to Screening.
- 111\. History of hypersensitivity to azithromycin or any components of its formulation.
- 112\. Use of special diet (including dragon fruit, grape fruit juice, mango, citrus, etc.), strenuous activities or other factors that may affect the disposition of the study medication within 14 days prior to Screening.
- 13\. Use of chocolate, food or beverages containing caffeine or xanthine within 48 hours prior to dosing.
- 14\. Use of products containing alcohol within 48 hours prior to dosing. 15. History of HIV, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HCVAb..
- 16\. Schizophrenia or other psychiatric illness..
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Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05437783
Start Date
January 1 2020
End Date
July 1 2022
Last Update
June 29 2022
Active Locations (1)
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1
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh, 1205