生物学的同等性とバイオアベイラビリティのジャーナル

概要

Oral Bioavailability and Pharmacokinetic Study of Clarithromycin in Different Dosage Forms in Iranian Healthy Volunteers

Katayoun Derakhshandeh, Gholamreza Bahrami, Bahareh Mohammadi and Elaheh Alizadeh

The objective of the present study was to study the bioavailability and pharmacokinetic parameters of three formulations of clarithromycin after oral administration in 12 normal adult male volunteers. Each subject received 500 mg of clarithromycin as two 250 mg tablets, one 500 mg tablet or suspension in a randomized crossover sequence. Blood samples were collected at selected time intervals up to 24 hours and plasma concentrations of CLR were determined using a validated HPLC method. The pharmacokinetics parameters including tmax, t1/2, Cmax, AUC, AUMC were determined from inspection of the individual subject concentration time curves and by model independent methods. The results showed that these parameters were not influenced by dosage form. Although higher maximum concentrations were achieved with the suspension, this was not statistically different from the other formulations. The tablets were not found to be statistically different from the suspension in any pharmacokinetic parameter. Bioequivalence of the test versus reference formulations was accepted for both AUC0–∞ and Cmax because the 90% CIs lie within the acceptable range of 80-125%. In the light of the results of the studies reported here, it can be concluded that CLR test formulations, i.e. tablet and suspension are bioequivalent to the respective reference formulations.