Pharmacokinetic interaction between cefaclor and bromhexine in healthy Chinese volunteers.
OBJECTIVE
To determine the pharmacokinetic interaction between cefaclor and bromhexine in healthy Chinese volunteers.


METHODS
Twelve subjects received a cefaclor (CEF) treatment, a bromhexine (BHX) treatment, and a co-treatment of CEF and BHX with a 3 x 3 Latin square design. The wash-out time between periods was 14 days. The plasma and urine drug concentrations of CEF and BHX were detected by HPLC-UV and LC/MS, respectively.


RESULTS
All the 12 volunteers completed the study. There were no significant differences in AUC 0-t and Cmax of CEF in logarithm between the single administration group of CEF and the co-administration group of CEF with BHX. Two one sided t-test showed that CEF was bioequivalent in the 2 groups. There were no significant differences in tmax, MRT, t1/2, and Clr between the 2 groups. Vd/F was significantly lower in the single CEF group than in the co-administration group of CEF and BHX. There were no significant differences of AUC 0-t and Cmax of BHX in logarithm between the single administration group of BHX and the co-administration group of BHX with CEF. Two one sided t-test showed that BHX was bioequivalent in the 2 groups. There were no significant differences in tmax, MRT, t1/2, Vd/F, and Clr between the 2 groups.


CONCLUSIONS
There is no significant pharmacokinetic parameter change in the drug absorption, metabolism, and excretion, but Vd/F of CEF significant increases in the co-administration of CEF with BHX. The co-administration of CEF and BHX has no adverse drug interaction. The increase of Vd/F may be a favorable drug interaction, which may be the mechanism of the synergistic effect of the 2 drugs.
Gong
Qian
Q
Research Institute of Drug Metabolism and Pharmacokinetics, School of Pharmaceutical Sciences, Central South University, Changsha 410083, China.
Hu
Zhe-yi
ZY
Huang
Zhi-zhuang
ZZ
Wang
Li-qing
LQ
Liu
Wen-fang
WF
Guo
Xin
X
Cao
Wei
W
Wang
Ting
T
Cheng
Ze-neng
ZN
D000328:Adult; D044466:Asian People; D001964:Bromhexine / Q000493:pharmacokinetics* / Q000494:pharmacology*; D002433:Cefaclor / Q000493:pharmacokinetics* / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D006801:Humans; D055815:Young Adult
D002433:Cefaclor; D001964:Bromhexine