A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO-PERIOD,CROSSOVER GLUCOSE CLAMP STUDY TO TEST FOR BIOEQUIVALENCEBETWEEN TWO RECOMBINANT HUMAN INSULIN ANALOGUES -WOCKHARDTS INSULIN ASPART INJECTION (100 IU/mL) ANDNOVORAPIDÂ® (100 Units/mL), IN HEALTHY SUBJECTS

Wockhardt Bio AG0 个研究点目标入组 56 人开始时间: 待定最近更新: 2022年11月21日

试验速览

暂无简介。

•1.Subjects weight within the normal range according to normal values for the Body Mass Index (18.5 to 27.0 kg/m 2, inclusive) with minimum of 50 kg weight.
•2. Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
•3. Non-smoker, defined as no nicotine/tobacco consumption for last six months.
•4. Have a negative urine screen for drugs of abuse.
•5. Have a negative alcohol breath analysis.

•1. Hypersensitivity to Insulin or related class of drugs.
•2. History or presence of significant cardiovascular, pulmonary,
•hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
•3. Subjects with hemoglobin levels <12.0 gm/di at screening or hemoglobinopathy.
•4. History or presence of alcoholism or drug abuse.

发起方