Objective To compare the pharmacokinetics and relative biological availability of Paracetatool orally disintegrating tablets and general tablets in healthy volunteers. Methods In a random two periods crossover study, ...Objective To compare the pharmacokinetics and relative biological availability of Paracetatool orally disintegrating tablets and general tablets in healthy volunteers. Methods In a random two periods crossover study, 19 healthy male Chinses volunteers received a single dose of Paracetamol 500mg of two formularies respectively. The plasma concentration of paracetamol was determined by HPLC method. The pharmacokinetic parameters of the two preparation and the relative biological availability of Paracetamol orally disintegrating tablets and general tablets were caculated with statistical analysis. Results The main pharmacokinetic parameters of paracetamol orally disintegrating tablets and general tablets were （ 31436. 70 ± 7062. 80 μg · h^ -1· L^-1 and （29871.40 ± 7965.04） μg · h^ -1· L^-1 for AUC0-1 （33295. 7 ±7663. 10） μg · h^ -1· L^-1 and（31845. 20 ± 8830. 83 ） μg · h^ -1· L^-1 forAUC0-1（9. 71 ±2. 78） μg/ml and（10. 36 ±3. 86） μg/mlfor Cmax; （0. 82 ±0. 45）h and （0. 74± 0.67）hforTmax;（2.90±0. 42）h and （3. 13 ±0. 67）h for T1/2ke;（0.24 ±0.04） and （0.23 ±0.04） for Ke; （4. 1481±0. 4492 ） and （4. 0771 ±0. 8131 ） for mean residence time （ MRT） , respectively. Variance analysis showed that there was significant difference in AUC0-12 and Cmax between the two preparations. Conclusion The paracetamol orally disintegrating tablets and general tablets are bioequivalent and the relative biological availability of Paracetamol orally disintegrating tablets is （ 108 ± 19） %.展开更多
文摘Objective To compare the pharmacokinetics and relative biological availability of Paracetatool orally disintegrating tablets and general tablets in healthy volunteers. Methods In a random two periods crossover study, 19 healthy male Chinses volunteers received a single dose of Paracetamol 500mg of two formularies respectively. The plasma concentration of paracetamol was determined by HPLC method. The pharmacokinetic parameters of the two preparation and the relative biological availability of Paracetamol orally disintegrating tablets and general tablets were caculated with statistical analysis. Results The main pharmacokinetic parameters of paracetamol orally disintegrating tablets and general tablets were （ 31436. 70 ± 7062. 80 μg · h^ -1· L^-1 and （29871.40 ± 7965.04） μg · h^ -1· L^-1 for AUC0-1 （33295. 7 ±7663. 10） μg · h^ -1· L^-1 and（31845. 20 ± 8830. 83 ） μg · h^ -1· L^-1 forAUC0-1（9. 71 ±2. 78） μg/ml and（10. 36 ±3. 86） μg/mlfor Cmax; （0. 82 ±0. 45）h and （0. 74± 0.67）hforTmax;（2.90±0. 42）h and （3. 13 ±0. 67）h for T1/2ke;（0.24 ±0.04） and （0.23 ±0.04） for Ke; （4. 1481±0. 4492 ） and （4. 0771 ±0. 8131 ） for mean residence time （ MRT） , respectively. Variance analysis showed that there was significant difference in AUC0-12 and Cmax between the two preparations. Conclusion The paracetamol orally disintegrating tablets and general tablets are bioequivalent and the relative biological availability of Paracetamol orally disintegrating tablets is （ 108 ± 19） %.
