The study will be performed on healthy volunteers..
Conditions
Interventions
Intervention 1: Intervention group: Receiving Iranian generic medicine in the first week and receiving brand medicine in the second week. Intervention 2: Intervention group: receiving the brand medica
Sponsors
Behshad Daroo Company
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Volunteer’s health (based on the results of physical examinations and clinical tests) Volunteer’s health (based on the results of physical examinations and clinical tests) Body mass index of 18.5-30 kg/m2 No history of allergy to tetracycline antibiotics and excipients used in the products formulations No administration of potent cytochrome p450 inhibitors 4 weeks before start of the study No history of diseases affecting the pharmacokinetic processes of the drug No history of smoking, alcohol and narcotics use Not being pregnant or breastfeeding Adherence to study criteria based on ethical commitment and informed consent Absence of severe liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2)
Exclusion criteria
Exclusion criteria: Pregnancy Tobacco or alcohol use, acute or chronic Failure to obtain any of the mentioned items regarding health tests Drug administration before and during the study Lack of adherence to study criteria Incidence of adverse reactions liver failure (Child Pugh B or C) or kidney failure (GFR<30 mL/min/1.73 m2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C max- Tmax- AUC0-t. Timepoint: 0 - 0.5 - 1 -1.5 - 2 - 2.5 - 3 - 3.5 - 4 -4.5 - 6 - 8 - 10 to 12 - 24 -48 -72 Hours after drug administration. Method of measurement: Drug analysis will be performed using a high-performance liquid chromatography (HPLC) equipped with a UV detector. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarshad Hashemian
Islamic Azad University
Outcome results
None listed