Bioequivalence of clavulanate potassium and amoxicillin (1:7) dispersible tablets in healthy volunteers.
To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets, a randomized cross-over study was conducted in 18 healthy volunteers. A single oral dose of 1,000 mg Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high-performance liquid chromatography. The main parameters of T were: for Clavulanate Potassium and Amoxicillin, Cmax: 2.46 +/- 1.11 micrograms/ml and 18.81 +/- 7.26 micrograms/ml, Tmax: 1.12 +/- 0.23 h and 1.30 +/- 0.34 h, AUC(0-6 h): 5.18 +/- 2.24 micrograms.h/ml and 45.09 +/- 14.53 micrograms.h/ml, t1/2: 1.43 +/- 0.44 h and 1.09 +/- 0.22 h., respectively. The relative bioavailability of T to R were 96.5 +/- 19.2% and 98.4 +/- 26.1%, respectively. Statistical analysis showed that the two formulations were bioequivalent.
Hu
Guoxin
G
Department of Pharmacology, Wenzhou Medical College, Wenzhou 325000.
Dai
Zongshun
Z
Long
Lihong
L
Han
Ying
Y
Hou
Shuxian
S
Wu
Li
L
D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000493:pharmacokinetics*; D004359:Drug Therapy, Combination / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency
D013607:Tablets; D019980:Amoxicillin-Potassium Clavulanate Combination