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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.- |
First Approval Date01 Jan 1985 |
/ RecruitingNot Applicable 妥布霉素吸入溶液长期给药方案治疗支气管扩张症伴铜绿假单胞菌感染患者中血清及肺内药物浓度及药代动力学/药效学与疗效评价研究
[Translation] Study on serum and lung drug concentrations, pharmacokinetics/pharmacodynamics and efficacy evaluation of long-term administration of tobramycin inhalation solution in the treatment of bronchiectasis patients with Pseudomonas aeruginosa infection
1) 评价妥布霉素吸入溶液在支气管扩张症(支扩症)伴铜绿假单胞菌(PA)感染患者中多次用药后在肺上皮衬液(ELF)和血清中的药物浓度及ELF到血液的渗透性;
2) 评价妥布霉素吸入溶液长疗程(12周)给药方案,治疗支扩症伴PA感染患者的细菌学指标变化;
3) 研究妥布霉素吸入溶液在支扩症伴PA感染患者中多次用药后的药代动力学(PK)/药效学(PD)与疗效相关性。
[Translation] 1) To evaluate the drug concentration of tobramycin inhalation solution in pulmonary epithelial lining fluid (ELF) and serum and the permeability of ELF to blood after multiple administration in patients with bronchiectasis (bronchiectasis) and Pseudomonas aeruginosa (PA) infection;
2) To evaluate the long-term (12-week) dosing regimen of tobramycin inhalation solution to treat the changes in bacteriological indicators in patients with bronchiectasis and PA infection;
3) To study the pharmacokinetics (PK)/pharmacodynamics (PD) and efficacy correlation of tobramycin inhalation solution in patients with bronchiectasis and PA infection after multiple administration.
一项评估JKN2306片在腹腔镜手术后患者中多次给药剂量递增及在腹腔镜/胸腔镜手术后患者中剂量探索的随机、双盲、安慰剂对照Ib/II期临床试验
[Translation] A randomized, double-blind, placebo-controlled Phase Ib/II clinical trial evaluating multiple dose escalation of JKN2306 tablets in patients undergoing laparoscopic surgery and dose escalation in patients undergoing laparoscopic/thoracoscopic surgery
Part 1腹腔镜手术后患者多次给药剂量递增(MAD)阶段:
主要目的:评价JKN2306片在腹腔镜手术后患者中多次给药的安全性、耐受性
次要目的:评价JKN2306片在腹腔镜手术后患者中多次给药的药代动力学(PK)特征
探索性目的:1)探索JKN2306片在腹腔镜手术后患者中多次给药的初步有效性;2) 探索JKN2306对转运体或代谢酶活性的影响。
Part2腹腔镜或胸腔镜手术后患者剂量探索阶段:
主要目的:评价JKN2306片在腹腔镜手术后患者中的有效性
次要目的:评价JKN2306片在腹腔镜或胸腔镜手术后患者中的安全性
探索性目的:1)探索JKN2306片在胸腔镜手术后患者中的初步有效性;2)在腹腔镜或胸腔镜手术后患者中,探索建立JKN2306群体药代动力学(popPK)模型
[Translation] Part 1 Multiple Ascending Dose (MAD) Phase for Patients Postoperatively Undergoing Laparoscopic Surgery:
Primary Objective: To evaluate the safety and tolerability of multiple-dose administration of JKN2306 tablets in patients undergoing laparoscopic surgery.
Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of multiple-dose administration of JKN2306 tablets in patients undergoing laparoscopic surgery.
Exploratory Objectives: 1) To investigate the preliminary efficacy of multiple-dose administration of JKN2306 tablets in patients undergoing laparoscopic surgery; 2) To investigate the effects of JKN2306 on the activities of transporters or metabolic enzymes. Part 2: Dose-finding Phase for Patients Following Laparoscopic or Thoracoscopic Surgery:
Primary Objective: To evaluate the efficacy of JKN2306 tablets in patients undergoing laparoscopic or thoracoscopic surgery.
Secondary Objective: To evaluate the safety of JKN2306 tablets in patients undergoing laparoscopic or thoracoscopic surgery.
Exploratory Objectives: 1) To investigate the preliminary efficacy of JKN2306 tablets in patients undergoing thoracoscopic or thoracoscopic surgery; 2) To explore the establishment of a population pharmacokinetic (popPK) model for JKN2306 in patients undergoing laparoscopic or thoracoscopic surgery.
/ RecruitingNot Applicable 雾化吸入妥布霉素治疗支气管扩张症急性加重患者伴铜绿假单胞菌感染的微生物学疗效研究:单中心,随机临床试验
[Translation] Microbiological efficacy of nebulized tobramycin in the treatment of Pseudomonas aeruginosa infection in patients with acute exacerbation of bronchiectasis: a single-center, randomized clinical trial
初步探索支扩症急性加重伴PA感染患者在全身抗感染基础上联合雾化吸入妥布霉素治疗,痰液PA 较治疗前的改变情况
[Translation] Preliminary exploration of the changes in sputum PA in patients with acute exacerbation of bronchiectasis and PA infection treated with tobramycin nebulized inhalation on the basis of systemic anti-infection.
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