Bioequivalence study of Azithromycin 250 mg

Bioequivalence study of Azithromycin 250 mg capsule 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

IRCT20200623047902N8

Enrollment

Registered

2021-09-28

Start date

2021-10-23

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

Healthy volunteers.

Interventions

Intervention 1: Intervention group: single dose, one oral capsule 250mg (Zithromax) manufactured by Pfizer, as reference product. Intervention 2: Intervention group: ntervention group: Single dose, on

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 Alcoholism and Narcoticism History of allergy to Azithromycin

Design outcomes

Primary

Measure	Time frame
Drug plasma concentration. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 h after drug administration. Method of measurement: HPLC -MASS-MASS.	—

Secondary

Measure	Time frame
Pharmacokinetic parameters. Timepoint: After intervention. Method of measurement: Theoretical and pahrmacokinetic equations.	—

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