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Objective To evaluate the bioavailability and bioequivalence of oseltamivir capsule in Chinese health male volunteers.Methods A randomized,two period,two treatment,two sequence crossover bioequivalence trial was designed,24 Chinese health volunteers were randomly divided into two groups,each group was orally given single dose oseltamivir phosphate(tamifla)or AMMS 607 capsule.The active metabolite oseltamivir carboxylate of oseltamivir in the plasma were determined by liquid chromatographic-tandem mass spectrometric(LC-MS/MS)method.The pharmacokinetics parameters and relative bioavailability were calculated to evaluate the bioequivalence of AMMS 607 and tamifla.Results Cmax of the AMMS 607 and tamifla were 602.07±153.27 ng·mL-1 and 620.09±132.39 ng·mL-1 respectively;tmax were 4.2±1.1 h and 4.8±1.0 h;t1/2β were 6.60±0.87 h and 6.61±0.83 h;MRT were 10.00±1.77 h and 10.40±1.62 h;AUC0-24 were 6285.88±1083.66 ng·h·mL-1 and 6546.01±1199.32 ng·h·mL-1;Compared with the reference of tamifla capsule,the bioavailability F0-tn of AMMS 607 capsule was 99.5±27.7%.The main pharmacokinetics parameters of AUC0-24,Cmax and Tmax showed no statistically significant difference between the two capsules.Conclusions The AMMS 607 capsule and tamifla capsule are bioequivalent.
Objective To evaluate the bioavailability and bioequivalence of oseltamivir capsule in Chinese health male volunteers. Methods A randomized, two period, two treatment, two sequence crossover bioequivalence trial was designed, 24 Chinese health volunteers were randomly divided into two groups, each group was orally given single dose oseltamivir phosphate (tamifla) or AMMS 607 capsule. The active metabolite oseltamivir carboxylate of oseltamivir in the plasma were determined by liquid chromatographic-tandem mass spectrometry (LC-MS / MS) method. The pharmacokinetics parameters and relative bioavailability were calculated to evaluate the bioequivalence of AMMS 607 and tamifla. Results Cmax of the AMMS 607 and tamifla were 602.07 ± 153.27 ng · mL-1 and 620.09 ± 132.39 ng · mL-1 respectively; tmax were 4.2 ± 1.1 h and 4.8 ± 1.0 h; t1 / 2β were 6.60 ± 0.87 h and 6.61 ± 0.83 h; MRT were 10.00 ± 1.77 h and 10.40 ± 1.62 h respectively; AUC0-24 were 6285.88 ± 1083.66 ng · h · mL-1 and 6546.01 ± 1199.32 ng · h · mL- Compared with the referenc e of tamifla capsule, the bioavailability F0-tn of AMMS 607 capsule was 99.5 ± 27.7%. The main pharmacokinetics parameters of AUC0-24, Cmax and Tmax showed no not significant difference between the two capsules. Conclusions The AMMS 607 capsule and tamifla capsule are bioequivalent.