Bioactivity and relative bioavailability of
domestic salcaltonin injection in Chinese healthy volunteers
Author(s): YANG Yi-Mei, XU Rong, CHEN Shu-juan, GU Shi-fen, CHEN Hui, ZENG Fan-Dian
Pages: 70-72
Year: 2001 Issue: 1
Journal: CHINESE PHARMACOLOGICAL BULLETIN
Keyword: 鲑鱼降钙素; 生物利用度; 生物活性;
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.
Pages: 70-72
Year: 2001 Issue: 1
Journal: CHINESE PHARMACOLOGICAL BULLETIN
Keyword: 鲑鱼降钙素; 生物利用度; 生物活性;
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.
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