Bioactivity and relative bioavailability of domestic salcaltonin injection in Chinese healthy volunteers
- VernacularTitle:国产鲑鱼降钙素注射液生物活性和人体生物利用度研究
- Author:
Yimei YANG
;
Rong XU
;
Shujuan CHEN
;
Shifen GU
;
Hui CHEN
;
Fandian ZENG
- Publication Type:Journal Article
- From:
Chinese Pharmacological Bulletin
2001;17(1):70-72
- CountryChina
- Language:Chinese
-
Abstract:
AIM To compare the bioactivity and bioavailability of domestic and imported salcaltonin injections in Chinese healthy volunteers. METHOD Using randomized cross design, to determine the concentrations of calcium and salcaltonin in serum of healthy volunteers after single dose of domestic and imported injections. RESULT Two preparations reduced concentration of calcium in serum obviously and there was no difference of mean changes of calcium between the two kinds of injections (P>0.05). The main pharmacokinetic parameters are: Cmax: (2.31±0.16) μg*L-1 and (2.44±0.20) μg*L-1；Tmax: (48.75±12.99) min and (52.50±16.31) min；T1/2ke: (92.93±11.86) min and (97.61±11.23) min；Ke: (0.0079±0.0023) min-1 and (0.0084±0.0014) min-1；AUC(0～360 min): (297.70±44.45) μg*min*L-1 and (313.64±46.03) μg*min*L-1 respectively in domestic and imported salcaltonin injections. The relative bioavailability of domestic formulation is 97.6%±25.6%. CONCLUSION The domestic and imported salcaltonin injections administered produce similar biological response and bioavailability and they are bioequivalent.
