Bioequivalence of clavulanate potassium and amoxicillin (1:7) dispersible tablets in healthy volunteers.
- Author:
Guoxin HU
1
;
Zongshun DAI
;
Lihong LONG
;
Ying HAN
;
Shuxian HOU
;
Li WU
Author Information
1. Department of Pharmacology, Wenzhou Medical College, Wenzhou 325000.
- Publication Type:Clinical Trial
- MeSH:
Adult;
Amoxicillin-Potassium Clavulanate Combination;
pharmacokinetics;
Drug Therapy, Combination;
pharmacokinetics;
Humans;
Male;
Tablets;
Therapeutic Equivalency
- From:
Journal of Huazhong University of Science and Technology (Medical Sciences)
2002;22(3):224-227
- CountryChina
- Language:English
-
Abstract:
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.
