RESUMO
The objective of this study was to assess average bioequivalence of two immediate released tablet formulations of 500-mg clarithromycin tablets in 24 healthy Thai male volunteers. In a randomized, single dose, fasting state, two-period, crossover study design with a 1-week washout period, each subject received a 500-mg clarithromycin tablet. Plasma samples were collected over a 24-hour period after oral administration and were analyzed by using a validated method using high performance liquid chromatography with electrochemical detection. Pharmacokinetic parameters were determined by using noncompartmental analysis. The time to reach the maximal concentration (tmax, h), the peak concentration (Cmax, ng/mL), and the area under the curve (AUC0-infinity, ng x h/mL) of the Reference and Test formulations were 2.0 +/- 0.8 vs. 2.2 +/- 0.9, 2793 +/- 1338 vs. 2642 +/- 1344, and 17912 +/- 7360 vs. 17660 +/- 7992, respectively. Relative bioavailability was 0.99. The 90% confidence interval of Cmax and AUC0-infinity were 82.6-112.1% and 84.7-112.0%. Bioequivalence between the Test and Reference formulation can be concluded.
Assuntos
Antibacterianos/farmacocinética , Claritromicina/farmacocinética , Adulto , Antibacterianos/administração & dosagem , Antibacterianos/efeitos adversos , Área Sob a Curva , Disponibilidade Biológica , Cromatografia Líquida de Alta Pressão , Claritromicina/administração & dosagem , Claritromicina/efeitos adversos , Estudos Cross-Over , Meia-Vida , Humanos , Masculino , Solubilidade , Comprimidos , Equivalência TerapêuticaRESUMO
OBJECTIVE: To evaluate the average bioequivalence of two formulations of 500 mg clarithromycin tablets in 24 healthy Thai male volunteers. METHODS: In a randomized, single dose, fasting state, two-period, crossover study design with a 1-week washout period, each subject received a 500 mg clarithromycin tablet. Plasma samples were collected over a 24-h period after administration and were analysed by using a validated HPLC-ECD method. Pharmacokinetic parameters were determined by using non-compartmental analysis. RESULTS: The time to reach the maximal concentration (tmax, h), the peak concentration (Cmax, ng/mL) and the area under the curve (AUC0- infinity, ng h/mL) of the Reference and Test formulations were 2.0 +/- 0.9 vs. 1.8 +/- 1.1, 3018 +/- 841 vs. 3014 +/- 752 and 23142 +/- 7348 vs. 22810 +/- 6027, respectively. The 90% confidence interval of Cmax and AUC0- infinity were 90.6-109.4 and 89.6-110.1%. CONCLUSION: Bioequivalence between the Test and Reference formulation can be concluded.
