Healthy volunteers (individuals without a specific disease)
Conditions
Interventions
Intervention 1: Intervention group: volunteers receive Co-Amoxiclav oral suspension 600 mg of amoxicillin with 42.9 mg of clavulanic acid per 5 ml (known as 643) manufactured by Dana Pharmaceutical Co
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: non-vegetarian diet Healthy in examinations at the time of entry into studies Informed consent form signer Not too fat or too thin.
Exclusion criteria
Exclusion criteria: Smoking, alcohol and drug use Allergy to co-amoxiclav Poor liver and kidney function, people with AIDS, hepatitis B or C, and syphilis Have abnormal blood tests for white blood cells, hemoglobin, and platelets History of serious digestive, hepatic, renal, and cardiovascular problems Patients with a history of chronic diseases such as blood pressure or blood lipids who have not taken medication in the previous two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome variables of this study included the pharmacokinetic parameters of co-amoxiclav in plasma, which were measured to assess bioequivalence between the test and reference products, including maximum plasma concentration (Cmax). Timepoint: 0 (before administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after oral administration of the drug; then, based on the concentration-time profile obtained from these points, Cmax and AUCs are calculated. Method of measurement: The outcome variable of this study is the plasma concentration of amoxicillin and clavulanic acid, which is determined through blood sampling and laboratory measurement. Blood samples are collected at predetermined times, plasma is separated by centrifugation and stored at appropriate temperature until analysis. Plasma concentration of amoxicillin and clavulanic acid is measured by high-performance liquid chromatography coupled to mass spectrometry (HPLC-MS/MS). This method has been validated in terms of accuracy, precision and sensitivity according to internationally recognized guidelines, and the resulting data are used to calculate pharmacokinetic parameters and assess bioequivalence.;Area under the concentration-time curve from zero to the last measurable time (AUC0–t). Timepoint: 0 (before administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after oral administration of the drug; then, based on the concentration-time profile obtained from these points, Cmax and AUCs are calculated. Method of measurement: High-performance liquid chromatography coupled to mass spectrometry (HPLC-MS/MS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactYousef Javadzadeh
Tabriz University of Medical Sciences
Outcome results
None listed