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Bioequivalence study of Azithromycin 500 mg tablet

Bioequivalence Study of Azithromycin 500 mg tablet manufactured by Sanamed company versus the originator brand in healthy volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200623047902N13
Enrollment
24
Registered
2022-01-22
Start date
2022-07-21
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

This study is performed on healthy volunteers..

Interventions

Intervention 1: Intervention group: single dose, one oral tablet 500mg (Zithromax) manufactured by Pfizer, as a reference product. Intervention 2: Intervention group: Single dose, one oral Azithromyci

Sponsors

Sanamed pharma company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease History of liver and kidney disease Alcohol and drug addiction History of allergy to Azithromycin

Design outcomes

Primary

MeasureTime frame
Drug plasma concentration. Timepoint: 0; 0.5; 1; 1.5; 2; 2.5; 3; 3.5; 4; 4.5, 5, 6; 8; 10; 12, 24, 48 and 72h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.

Secondary

MeasureTime frame
Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElham Ghasemian

Islamic Azad University

Ghasemian_elham@yahoo.com+98 21 6640 3568

Outcome results

None listed

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