/ RecruitingNot Applicable 健康志愿者单次空腹口服埃索美拉唑镁肠溶胶囊随机、开放、单剂量、两周期交叉设计生物等效临床试验
[Translation] A randomized, open-label, single-dose, two-period crossover bioequivalence clinical trial of a single oral administration of esomeprazole magnesium enteric-coated capsules on an empty stomach in healthy volunteers
评价成都纵联医疗健康科技有限公司研制的埃索美拉唑镁肠溶胶囊与原研参比制剂是否生物等效。
[Translation] To evaluate whether the esomeprazole magnesium enteric-coated capsules developed by Chengdu Zonglian Medical Health Technology Co., Ltd. are bioequivalent to the original reference preparation.
/ Not yet recruitingNot Applicable 吲哚布芬片在中国健康志愿者中空腹及餐后状态下的人体生物等效性试验
[Translation] Human bioequivalence study of indobufen tablets in Chinese healthy volunteers under fasting and fed conditions
主要目的
观察吲哚布芬片在中国健康受试者中单次口服给药后吲哚布芬的体内动力学过程,估算相应的药代动力学参数,并以Pfizer Italia S.r.l持证的的吲哚布芬片IBUSTRIN®为参比制剂,进行生物等效性评价。
次要目的
观察吲哚布芬片受试制剂和参比制剂在健康人体中的安全性。
[Translation] Primary objective
To observe the in vivo kinetics of indobufen tablets after a single oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and evaluate the bioequivalence of indobufen tablets IBUSTRIN® certified by Pfizer Italia S.r.l as the reference preparation.
Secondary objective
To observe the safety of the test preparation and reference preparation of indobufen tablets in healthy humans.
100 Clinical Results associated with Chengdu Zonglian Medical Health Technology Co., Ltd.
0 Patents (Medical) associated with Chengdu Zonglian Medical Health Technology Co., Ltd.
100 Deals associated with Chengdu Zonglian Medical Health Technology Co., Ltd.
100 Translational Medicine associated with Chengdu Zonglian Medical Health Technology Co., Ltd.