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Mechanisminsulin modulators |
Active Org.- |
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Active Indication- |
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Drug Highest PhasePending |
First Approval Ctry. / Loc.- |
First Approval Date- |
冻干重组人胰岛素原C肽I期临床研究(单次给药和食物影响的药动学试验)
[Translation] Phase I clinical study of freeze-dried recombinant human proinsulin C-peptide (pharmacokinetic study of single-dose administration and food effects)
评价单次给予不同剂量的冻干重组人胰岛素原C肽粉针剂在健康中国男性和女性受试者中的药动学特点及其食物对其药动学特征的影响。
[Translation] To evaluate the pharmacokinetic characteristics of single administration of different doses of freeze-dried recombinant human proinsulin C-peptide powder injection in healthy Chinese male and female subjects and the effect of food on its pharmacokinetic characteristics.
冻干重组人胰岛素原C肽I期临床研究(单次给药安全耐受性试验)
[Translation] Phase I clinical study of freeze-dried recombinant human proinsulin C-peptide (single-dose safety and tolerance test)
观察冻干重组人胰岛素原C肽在中国健康受试者中单次给药的安全性和耐受程度,为单剂量给药药代动力学试验和连续多次给药药代动力学试验及连续多次给药的安全耐受性试验提供科学依据,并为II期和III期临床试验安全给药剂量的确定提供参考。
[Translation] To observe the safety and tolerability of a single dose of freeze-dried recombinant human proinsulin C-peptide in healthy Chinese subjects, to provide a scientific basis for single-dose pharmacokinetic trials and continuous multiple-dose pharmacokinetic trials and continuous multiple-dose safety and tolerability trials, and to provide a reference for determining the safe dosage for Phase II and Phase III clinical trials.
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