Comparative in vivo evaluation of 2 Azithromycin 250 mg Tablet and Zithromax 250 Tablet formulations.
- Conditions
- Acute pharyngitis.Acute pharyngitis
- Registration Number
- IRCT20180620040164N48
- Lead Sponsor
- Cosar Pharmaceutical Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 24
Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range between 18.5 - 30 kg/m2.
Subjects that have normal vital signs.
Subjects who agree with patient consent form.
Known sensitivity to the tested products, hypertension (blood pressure in the standing position after at least 5 minutes of rest, systolic blood pressure greater than or equal to 140 mmHg, and diastolic blood pressure greater than or equal to 90 mmHg).
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
loss of more than 500 milliliters of blood in less than 7 days prior to testing.
Subjects with significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).
- Secondary Outcome Measures
Name Time Method AUC (Area Under the Concentration-Time Curve). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA).