ABSTRACT
Prescription of generic products is a way to reduce health expense. Bioequivalence is the most appropriate procedure to evaluate the quality and therapeutic efficacy of a generic product. Generic prescriptions are a strategic choice in Tunisia. We expose in this work, a bioequivalence study witch compare a generic [test] product: DIABENIL manufactured by a Tunisian pharmaceutical industry Dar Essaidaly to the innovative [reference] product: DAONIL of Aventis pharma laboratories. The bioequivalence of two glibenclamide 5-mg tablets was determined in healthy human, adult volunteers after a single dose in a randomized cross-over in double blind study. Test and reference were administered to twenty-four healthy volunteers of both sexes after overnight fasting. In total, 15 Blood samples were collected before and following the administration of the drug. Serum concentrations of glibenclamide were determined by validated HPLC method. The pharmacokinetic parameters'AUCOt, AUCO, Cmax and tmax were tested for bioequivalence. All parameters showed bioequivalence between both formulations as their confidence intervals were within the bioequivalence acceptable range of 0.80-1.25 limits. We conclude that the two formulations exhibited comparable pharmacokinetic profiles and that the two products can be considered interchangeable in medical practice
ABSTRACT
Arterial hypertension is a worldwide health problem with multiple origins. Its management remains difficult, particularly because of the pathology dependence on human lifestyle. Several ethno pharmaceutical are used to treat hypertension. Herein we investigated, for the first time, the effect of the water-boiled extract of Artemisia campestris on Human hemodynamic system. To do so, the blood pressure parameters of two groups of adult volunteers (smokers and non-smokers) were recorded before and each 15 minutes after drinking 20 ml of the boiled extract (20g of dried leaves / 1 L of water). The diastolic pressure and heart rate significantly diminished following the treatment, in both smoker and non-smoker men. In exception to a punctual reduction at 45 minutes in non- smokers, the systolic pressure did not significantly change. The classification of subjects in accordance to their hypertension statute at each time-point of recording, showed an important reduction of the stage 2 in smoking men, following the consumption of the extract. It is concluded that the water-boiled extract of Artemisia campestris could tip over arterial hypertension, especially in smokers. It is suggested that the mechanism of such effect involves epinephrine synthesis or binding to its receptor inhibition.