人胰岛素生物类似药(Wockhardt Ltd.)(Insulin human biosimilar(Wockhardt Ltd.)) - 药物靶点：INSR_在研适应症：1型糖尿病_专利_临床

概要

基本信息

药物类型

生物类似药、激素

别名

Wosulin、Wosulin Pen、Wosulin Pen Royale

+ [1]

靶点

INSR

作用方式

激动剂

作用机制

INSR激动剂(胰岛素受体激动剂)

治疗领域

免疫系统疾病内分泌与代谢疾病

在研适应症

1型糖尿病

非在研适应症-

原研机构

Wockhardt Ltd.

在研机构

Wockhardt Ltd.

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

印度 (2003-10-01),

1型糖尿病

最高研发阶段(中国)-

特殊审评-

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关联

10

项与人胰岛素生物类似药(Wockhardt Ltd.) 相关的临床试验

CTRI/2021/05/033411

/ Not yet recruitingN/A

A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO TREATMENT, TWO-PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST FOR BIOEQUIVALENCE BETWEEN WOCKHARDTâ??S WOSULINÂ® 30/70 (100 IU/mL) {BIPHASIC ISOPHANE INSULIN INJECTION/ 70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION (r-DNA ORIGIN)} AND HUMULINÂ® 70/30 (100 U/mL) {70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION (rDNA origin)} IN HEALTHY SUBJECTS. - Clamp Study

开始日期2021-05-10

申办/合作机构

Wockhardt Bio AG

CTRI/2021/04/032915

/ RecruitingN/A

A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO TREATMENT, TWO-SEQUENCE, TWO PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST FOR BIOEQUIVALENCE BETWEEN WOCKHARDTâ??S WOSULINÂ® N (100 IU/mL) {ISOPHANE INSULIN HUMAN, SUSPENSION, r-DNA ORIGIN} AND HUMULINÂ® N (100 U/mL) {HUMAN INSULIN (r-DNA ORIGIN) ISOPHANE SUSPENSION}, IN HEALTHY SUBJECTS. - Clamp Study

开始日期2021-04-19

申办/合作机构

Wockhardt Bio AG

CTRI/2015/05/005801

/ TerminatedN/A

A double-blind, randomized, single dose, two-period, two-way crossover bioequivalence study between two Recombinant DNA human soluble Insulin Formulations - Wockhardtâ??s rDNA human regular Insulin Injection (Wosulin R) 100 IU/mL with ActrapidÂ® HM PenfillÂ® (Regular, Human Insulin injection [rDNA origin] IP) 100 IU/mL, 3.0 mL of Imported by: Novo Nordisk India Private Limited and Manufactured by: Novo Nordisk Producao Farmaceutica do Brasil Ltda. Brazil 39404004, INDIA in healthy, adult, male subjects under fasting condition. - PK PD Trial

开始日期2015-06-01

申办/合作机构

Wockhardt Ltd.

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