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Drug Highest PhaseNDA/BLA |
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在口服降糖药疗效不佳的2型糖尿病受试者中评估联合重组人胰岛素肠溶胶囊治疗的有效性和安全性的随机、双盲、安慰剂对照研究
[Translation] A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of combined treatment with recombinant human insulin enteric-coated capsules in subjects with type 2 diabetes who are inadequately responsive to oral hypoglycemic drugs
主要目的:在口服降糖药血糖控制不佳的2型糖尿病受试者中,评估联合重组人胰岛素肠溶胶囊(ORMD-0801明胶软胶囊,以下简称 ORMD-0801)治疗的有效性。
次要目的:在口服降糖药疗效不佳的2型糖尿病受试者中,评估联合ORMD-0801治疗的安全性及免疫原性。
[Translation] Primary objective: To evaluate the efficacy of combined treatment with recombinant human insulin enteric-coated capsules (ORMD-0801 gelatin soft capsules, hereinafter referred to as ORMD-0801) in subjects with type 2 diabetes who have poor blood sugar control with oral hypoglycemic drugs.
Secondary objective: To evaluate the safety and immunogenicity of combined treatment with ORMD-0801 in subjects with type 2 diabetes who have poor efficacy with oral hypoglycemic drugs.
一项在健康受试者中评估ORMD-0801明胶软胶囊单次给药的安全性、耐受性、药代动力学及药效学特征的I期临床研究
[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single-dose ORMD-0801 gelatin soft capsule in healthy subjects
主要目的: 评价ORMD-0801明胶软胶囊在健康志愿者中单次给药后的安全性和耐受性。 次要目的: 评价健康志愿者单次口服ORMD-0801明胶软胶囊后对血糖的药效动力学作用及对体内C肽、GLP-1的影响; 评价受试者单次口服ORMD-0801明胶软胶囊的药代动力学特征。
[Translation] Primary objective: To evaluate the safety and tolerability of ORMD-0801 gelatin soft capsules after a single dose in healthy volunteers. Secondary objective: To evaluate the pharmacodynamic effects of ORMD-0801 gelatin soft capsules on blood glucose and the effects on C-peptide and GLP-1 in vivo after a single oral dose in healthy volunteers; To evaluate the pharmacokinetic characteristics of ORMD-0801 gelatin soft capsules after a single oral dose in subjects.
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