Bioequivalence study of rifampicin in fixed-dose combination of rifampicin and isoniazid vs. separate formulations.
The benefits of fixed-dose combinations of antituberculosis agents are well recognized by the World Health Organization (WHO) and International Union Against Tuberculosis and Lung Disease (IUATLD) and preferred over separate formulations. Therefore, a comparative bioequivalence study of rifampicin and isoniazid together in a fixed-dose combination and separately (at the same dose levels) was performed on a group of 12 healthy subjects. The study was designed as a single-blind, crossover experiment. Nine blood samples were collected from each subject over a period of 24 h. The plasma concentrations of rifampicin were assessed by a method developed in this laboratory. Various pharmacokinetic parameters of rifampicin such as AUC, Cmax, Tmax and t1/2 were also calculated. The study demonstrates that a fixed-dose combination (test formulation) and separate formulations (standard formulations) are bioequivalent for rifampicin.
Panchagnula
R
R
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Punjab, India. niper@chd.nic.in
Singh
I
I
Kaur
K J
KJ
Kaul
C L
CL
D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage; D018592:Cross-Over Studies; D004338:Drug Combinations; D006801:Humans; D066298:In Vitro Techniques; D007538:Isoniazid / Q000008:administration & dosage*; D008297:Male; D012293:Rifampin / Q000008:administration & dosage* / Q000097:blood*; D013810:Therapeutic Equivalency; D013997:Time Factors
D000995:Antitubercular Agents; D004338:Drug Combinations; D007538:Isoniazid; D012293:Rifampin