Bioequivalence evaluation of Azithromycin Capsule 500 mg of Mahban Pharmaceutical company

Bioequivalence evaluation of Azithromycin Capsule 500 mg of Mahban Pharmaceutical company in comparison with brand drug

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200625047913N15

Enrollment

Registered

2024-06-20

Start date

2024-08-20

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

None listed

Interventions

Intervention 1: Intervention group: Azithromycin 500 mg Capsules made by Mahban pharmaceutical company from Iran will be prescribed in the first week at fast condition and blood samples will be drawn

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 18 to 45 years old Sex: Males and/or females BMI: 18.5 to 24.9 Kg/m2 Being able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent A physical examination with no clinically significant finding and laboratory normal tests

Exclusion criteria

Exclusion criteria: Chronic or acute use of any medication at least 1 week before the start of the study History of diseases affecting the pharmacokinetic processes of the drug Pregnancy Lactation

Design outcomes

Primary

Measure	Time frame
Plasma concentration. Timepoint: 0? 0.5? 1? 5/1? 2? 5/2? 3? 5/3? 4? 5? 6? 8? 12? 24? 48, 72 hr. Method of measurement: LC MS MS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaranak Salmannejad

School of Pharmacy; Alborz University of Medical Sciences

salmannejad.f@gmail.com+98 26 3256 7175

Outcome results