2种奥卡西平片在中国健康受试者中空腹及餐后单次口服给药的安全性研究

Safety studies of two oxcarbazepine tablets after single-dose oral administration under fasting and fed conditions in healthy Chinese volunteers

目的 研究国产奥卡西平片(商品名:万仪)与原研药奥卡西平片(商品名:曲莱)在中国健康受试者中空腹和餐后给药状态下单次给药的安全性。方法 56例健康受试者空腹状态单次给药后进行随机、开放、2个周期、两交叉试验。75例健康受试者进食高脂餐后单次给药进行随机、开放、3个周期、部分重复交叉试验。第1个周期给药后,经过7 d清洗期,进行下一个周期交叉给药。每个周期给药前1.0 h内及给药后(3.0±0.5)、(6.0±0.5)、(12.0±0.5)、(24.0±1.0)、(48.0±1.0)h测量受试者坐位生命体征(包括体温、脉搏及血压)。采用SAS 9.4软件统计分析两种药物的安全性。结果 空腹试验1例受试者脱落,55例完成试验。空腹试验万仪出现2例(3.6%,2/55)受试者发生不良反应,曲莱出现11例(19.6%,11/56)受试者发生不良反应,均无严重不良反应。餐后试验4例受试者脱落,71例完成试验。餐后试验万仪出现10例(14.1%,10/71)受试者发生不良反应,曲莱出现16例(21.6%,16/74)受试者发生不良反应,均无严重不良反应。2种制剂不良反应的发生率、种类、严重程度和转归无显著差异。结论 中国健康受试者空腹或餐后单次服用仿制奥卡西平片(万仪)或原研药奥卡西平片(曲莱)后,安全性良好。

Objective To study the safety of generic oxcarbazepine tablets(trade name:Wanyi)and reference listed drug oxcarbazepine tablets(trade name:Trileptal)after single-dose oral administration under fasting and fed conditions in healthy Chinese volunteers.Methods A randomized,open,two-period,twocrossover safety trial was conducted in 56 healthy Chinese volunteers under fasting conditions.A randomized,open,three-period,three-way crossover safety trial was conducted in 75 healthy Chinese volunteers under fed conditions.Single dose administration was carried out during the next period after 7-d washout.Each period the sitting vital signs of the subjects were measured within 1.0 h before administration and(3.0±0.5),(6.0±0.5),(12.0±0.5),(24.0±1.0)and(48.0±1.0)h after administration(including temperature,pulse and blood pressure).The safety results of the two drugs were statistically analyzed with SAS 9.4 software.Results 1 subject dropped out and 55 subjects completed the fasting trial.Under fasting conditions,adverse reactions occurred in 2 subjects(3.6%,2/55)in patients taking Wanyi and in 11 subjects(19.6%,11/56)in patients taking Trileptal,none of which had serious adverse reactions.4 subjects dropped out and 71 subjects completed the fed trial.Adverse reactions occurred in 10 subjects(14.1%,10/71)in patients taking Wanyi and in 16 cases(21.6%,16/74)in patients taking Trileptal,none of which had serious adverse reactions.The results showed that there was no significant difference in the incidence,type,severity or outcome of adverse reactions between the two preparations.Conclusion Generic oxcarbazepine tablets(trade name:Wanyi)and reference listed drug oxcarbazepine tablets(trade name:Trileptal)are safe in healthy Chinese volunteers under fasting and fed conditions.