Bioactivity and relative bioavailability of domestic salcaltonin injection in Chinese healthy volunteers / 中国药理学通报

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.