Comparative in vivo evaluation of 2 Azithromycin 250 mg Tablet and Zithromax 250 Tablet formulations.

Comparative bioequivalence study of Azithromycin 250 mg Tablet of Cosar Pharmaceutical Co. and Zithromax® of Pfizer as reference in 24 healthy male under fasting condition

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180620040164N48

Enrollment

Registered

2023-08-19

Start date

2023-10-13

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pharyngitis. Acute pharyngitis

Interventions

Intervention 1: ntervention group1: Azithromycin 250 mg Tablet , produced by Cosar Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this prod

Eligibility

Sex/Gender

Male

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 24, 48 and 72 hours after intervention.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

Measure	Time frame
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 Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 24, 48 and 72 hours after intervention.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).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Aghaei

Noor Research & Development Institute

partochem@gmail.com+98 21 6600 4027

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026