A PILOT STUDY TO COMPARE PHARMACOKINETICS ANDPHARMACODYNAMICS BETWEEN WOCKHARDTâ??S BIPHASIC INSULINASPART INJECTION (30/70) AND NOVOMIXÂ® 30, IN HEALTHY MALESUBJECTS.

Wockhardt Bio AG0 个研究点目标入组 15 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Subjectâ??s weight within the normal range according to normal values for the Body Mass Index (18.50 to 27.00 kg/m2, both inclusive) with minimum of 50 kg weight.
•Subjects with normal health as determined by medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
•Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
•Subjects having clinically acceptable chest X-Ray (PA view).
•Non-smoker, defined as no nicotine consumption for last six months.
•7. Have a negative urine screen for drugs of abuse {including amphetamine, barbiturate, benzodiazepines, marijuana (THC), cocaine, and morphine (opiate)}.
•Have a negative alcohol breath analysis.
•Subjects willing to adhere to the protocol requirements and are agreed for verbal and written consent to audio-visual recording of the discussion of consent process and agreed to provide the signed and dated informed consent before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
•Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.

•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 <12.00 gm/dl at screening or hemoglobinopathy will not be eligible for the study
•4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study drug administration.
•5. History or presence of significant alcoholism or drug abuse in the past one year.
•6. HbA1c values (at screening) more than 5.7%

发起方