Investigating the in vivo bioequivalence of Azithromycin 250 mg capsule

In vivo bioequivalence study of Azithromycin 250 mg capsule manufactured by Ani Darman Co. compared with Zithromax®

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210519051345N13

Enrollment

Registered

2022-08-15

Start date

2022-09-11

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

In the present study, ?in vivo bioequivalence of Azithromycin 250 mg capsules (Ani Darman Co.) compared to Zithromax®.

Interventions

Intervention 1: Intervention group: Intervention group will receive a single test drug product. Blood samples will be collected for 72 hours at the mentioned times after drug administration and the co

Eligibility

Sex/Gender

All

Age

18 Years to 59 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney)

Exclusion criteria

Exclusion criteria: Smoking, History of cardiovascular disease, liver disease and kidney disease, Pregnancy, Alcohol and drug addiction, History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: 0.5-72 hours in predetermined time intervals after drug administration. Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results

None listed

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