[Comparative study of azithromycin pharmacokinetics in healthy volunteers in open cross randomized procedure].
A method of quantitative determination of azithromycin in HPLC with mass spectrometric detection was developed. The detection limit is 0.5 ng/ml. The method was used in the study of pharmacokinetics and bioequivalence of Zi-Factor (capsules of 250 mg of azithromycin made by Veropharm, Russia) vs. reference-drug. The pharmacokinetic study was performed by the open cross randomized procedure in 18 volunteers. The pharmacokinetic parameters required for estimation of the drug bioequivalence were calculated. The statistical analysis of the pharmacokinetic parameters revealed bioequivalence of Zi-Factor and the reference-drug.
Pisarev
V V
VV
National Research Centre of Antibiotics, State Research Centre of Prophylactic Medicine, Moscow.
Moskaleva
N E
NE
Zverkov
Iu B
IuB
Smirnova
L B
LB
Belolipetskaia
V G
VG
Sukhanov
Ia V
IaV
D000284:Administration, Oral; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D017963:Azithromycin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D006801:Humans; D013058:Mass Spectrometry; D013810:Therapeutic Equivalency
D000900:Anti-Bacterial Agents; D017963:Azithromycin