CTRI/2026/02/104468尚未招募不适用
A Randomized, Single Center, Double Blind, Two-Period, Crossover Glucose Clamp Study to test for bioequivalence between two Recombinant Human Insulin Analogues - Wockhardt’s Biphasic Insulin Aspart Injection (30 by 70) and NovoMix® 30, in Healthy Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
研究概览
简要总结
The study objective is to test for bioequivalence based on pharmacokinetic and pharmacodynamic parameters of two Recombinant Human Insulin Analogues -Wockhardt’s Biphasic Insulin Aspart Injection (30/70) and NovoMix® 30 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects aged between 18 and 45 years (both inclusive).
- •Subjects weight within the normal range according to normal values for the Body Mass Index (18.5 to 27.0 kg per hr, 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 or tobacco consumption for last six months.
- •Have a negative urine screen for drugs of abuse.
- •Have a negative alcohol test.
- •Subjects willing to adhere to the protocol requirements.
- •Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.
- •Subject agrees to be sexually abstinent or agree to use two approved methods of contraception when engaging in sexual activity from screening till 90 days following the last administration of the study drug and to not donate sperm during this period of time.
- •In the event that the sexual partner is surgically sterile, contraception is not necessary.
排除标准
- •Hypersensitivity to Insulin or related class of drugs.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Subjects with hemoglobin levels less than 12.5 gm per dl at screening or hemoglobinopathy.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- •History or presence of alcoholism or drug abuse in the past one year.
- •Subjects who are Hepatitis B or C or HIV or VDRL positive.
- •History or presence of significant asthma, urticaria or other allergic reactions.
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •History or presence of cancer.
- •Family history of diabetes mellitus.
- •Difficulty in donating blood.
- •Major illness in the past.
- •Subjects who donated 350 ml or more blood within 90 days.
- •Subjects who have received any investigational drug within 90 days from screening visit.
- •Use of prescription and non-prescription drugs, except routine vitamins, within 2 weeks prior to screening/randomization.
研究者
Dr Nilesh Lomte
Wockhardt Limited
研究点 (1)
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