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Bioequivalence evaluation of Azithromycin Capsule 500 mg/ Suspension 200 mg/5 ml manufactured by Dora Darou company

Bioequivalence evaluation of Azithromycin Capsule 500 mg/ Suspension 200 mg/5 ml manufactured by Dora Darou company

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200625047913N3
Enrollment
24
Registered
2020-12-11
Start date
2021-01-20
Completion date
Unknown
Last updated
2021-01-05

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: Prescription of Azithromycin 500 mg capsule/200mg/5ml suspension manufactured by Dorsa Darou company from Iran in the first week. Intervention 2: Control group: Pre

Sponsors

Hezareh Sevom Futuristic Pharmacist
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 18 to 45 years old Sex: Males and/or non-pregnant, non-lactating females BMI: 18.5 to 24.9 weight in kg/(height in meter) 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, Do not take any chronic or acute medication for at least 1 week before the start of the study No history of diseases affecting the pharmacokinetic processes of the drug

Exclusion criteria

Exclusion criteria: History of allergic responses to Azithromycin or other related drugs, or any of its formulation ingredients Have significant diseases (which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system) or clinically significant abnormal findings during screening Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period History or evidence of drug dependence or of alcoholism or of moderate alcohol use History of difficulty with donating blood or difficulty in accessibility of veins Volunteers who have received a known investigational drug within five elimination half life of the administered drug prior to the initial dose of study drug or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the initial dose of study drug, whichever is greater found positive in urine test for drugs of abuse done before check-in of period History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption

Design outcomes

Primary

MeasureTime frame
Plasma concentration. Timepoint: 0,0.5, 1, 1.5, 2, 2.5, 3,3.5,4,5,6,8,12,24,48,72 hour. Method of measurement: LC MS MS.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaranak Salmannejad

Alborze University of Medical Sciences, School of Pharmacy

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

Outcome results

None listed

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