|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date26 May 2021 |
Target- |
Mechanism- |
|
Originator Org.- |
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
Active Org.- |
Originator Org.- |
Active Indication- |
|
Drug Highest PhasePending |
First Approval Ctry. / Loc.- |
First Approval Date- |
注射用磷酸左奥硝唑酯二钠治疗盆腔厌氧菌感染的有效性和安全性的随机、双盲平行对照临床研究
[Translation] A randomized, double-blind, parallel controlled clinical study on the efficacy and safety of levoornidazole disodium phosphate injection in the treatment of pelvic anaerobic infection
以左奥硝唑氯化钠注射液(优诺安®)对比,评价注射用磷酸左奥硝唑酯二钠在不同给药方案下治疗盆腔厌氧菌感染的安全性和有效性。
[Translation] To evaluate the safety and efficacy of levornidazole disodium phosphate injection in the treatment of pelvic anaerobic infections at different dosing regimens, compared with levornidazole sodium chloride injection (Unoan®).
健康志愿受试者单次静脉输注磷酸左奥硝唑酯二钠的药代动力学试验
[Translation] Pharmacokinetic study of single intravenous infusion of levonidazole disodium phosphate in healthy volunteers
1.静脉输注15N-磷酸左奥硝唑酯二钠后能否迅速转化为15N-左奥硝唑;并与注射近似等摩尔左奥硝唑后,体内左奥硝唑的量进行比较;并评价其药代动力学特征。
2.静脉输注磷酸左奥硝唑酯二钠后能否迅速转化为左奥硝唑;并与注射近似等摩尔15N-磷酸左奥硝唑酯二钠后,体内15N-磷酸左奥硝唑酯二钠的量进行比较;评价其药代动力学特征。
[Translation] 1. Whether 15N-levo-ornidazole disodium phosphate can be rapidly converted into 15N-levo-ornidazole after intravenous infusion; and compare the amount of levo-ornidazole in the body after injection of approximately equimolar levo-ornidazole; and evaluate its pharmacokinetic characteristics.
2. Whether 15N-levo-ornidazole disodium phosphate can be rapidly converted into levo-ornidazole after intravenous infusion; and compare the amount of 15N-levo-ornidazole disodium phosphate in the body after injection of approximately equimolar 15N-levo-ornidazole disodium phosphate; and evaluate its pharmacokinetic characteristics.
单次和多次静滴注射用磷酸左奥硝唑酯二钠在中国健康志愿者Ⅰ期临床耐受性和药代动力学试验
[Translation] Phase I clinical tolerability and pharmacokinetic study of single and multiple intravenous injection of levonidazole disodium phosphate in healthy Chinese volunteers
研究注射用磷酸左奥硝唑酯二钠在中国健康志愿者单次和多次给药后的药代动力学(PK);
研究注射用磷酸左奥硝唑酯二钠在中国健康志愿者单次给药的耐受剂量
评价研究注射用磷酸左奥硝唑酯二钠单次和多次给药后的安全性。
[Translation] To study the pharmacokinetics (PK) of levonidazole disodium phosphate for injection after single and multiple administration in healthy Chinese volunteers;
To study the tolerated dose of levonidazole disodium phosphate for injection in healthy Chinese volunteers after single administration
To evaluate the safety of levonidazole disodium phosphate for injection after single and multiple administration.
100 Clinical Results associated with Nanjing Hailing Traditional Chinese Medicine Pharmaceutical Art Technical Research Co Lt
0 Patents (Medical) associated with Nanjing Hailing Traditional Chinese Medicine Pharmaceutical Art Technical Research Co Lt
100 Deals associated with Nanjing Hailing Traditional Chinese Medicine Pharmaceutical Art Technical Research Co Lt
100 Translational Medicine associated with Nanjing Hailing Traditional Chinese Medicine Pharmaceutical Art Technical Research Co Lt