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/ CompletedNot Applicable 评估空腹及餐后口服吲达帕胺缓释片后体内生物等效性的随机、开放、单剂量、双周期、交叉研究
[Translation] A randomized, open-label, single-dose, two-period, crossover study to evaluate the in vivo bioequivalence of fasting and fed oral indapamide extended-release tablets
本试验旨在研究单次空腹和餐后口服真奥金银花药业有限公司研制、生产的吲达帕胺缓释片(1.5 mg)的药代动力学特征;以Les Laboratoires Servier生产的吲达帕胺缓释片(FLUDEX®,1.5 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The aim of this study was to investigate the pharmacokinetic characteristics of indapamide sustained-release tablets (1.5 mg) developed and produced by Zhenao Honeysuckle Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration; using indapamide sustained-release tablets (FLUDEX®, 1.5 mg) produced by Les Laboratoires Servier as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.
/ Not yet recruitingPhase 1 评价ADLS1026注射液在中国健康参与者中单次/多次给药的安全性、耐受性及药代动力学研究
[Translation] A study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple doses of ADLS1026 injection in healthy Chinese participants
主要目的:1)评价ADLS1026注射液在健康参与者中单次/多次给药后的安全性和耐受性。
次要目的:1)评估ADLS1026注射液在中国健康参与者中单次给药后的药代动力学特征;
2)评估ADLS1026注射液在中国健康参与者中多次给药后的药代动力学特征;
3)探索ADLS1026注射液的药效学特征。
[Translation] Primary objectives: 1) Evaluate the safety and tolerability of ADLS1026 injection after single and multiple doses in healthy participants.
Secondary objectives: 1) Evaluate the pharmacokinetic profile of ADLS1026 injection after a single dose in healthy Chinese participants;
2) Evaluate the pharmacokinetic profile of ADLS1026 injection after multiple doses in healthy Chinese participants;
3) Explore the pharmacodynamic profile of ADLS1026 injection.
100 Clinical Results associated with Zhenao Honeysuckle Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhenao Honeysuckle Pharmaceutical Co., Ltd.
100 Deals associated with Zhenao Honeysuckle Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhenao Honeysuckle Pharmaceutical Co., Ltd.