CTRI/2017/08/009251已完成1 期
A Randomized, Single Center, Double Blind, Two Treatment, Two-Period, Crossover Glucose Clamp Study To Test For Bioequivalence Between Wockhardt’s Consegna™ - 30/70 (Bi Phasic Isophane Insulin 30/70 Injection 200 IU) and Mixtard® 30/70 (100 IU), In Healthy Subjects.
Wockhardt Pvt Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年2月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pharmacokinetic parameters (Cmax and AUC0-24h)
研究概览
简要总结
Study yet to be inititated
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •1.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.
- •5.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.
- •Subject agree 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 not to 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 12.00 gm/dl at screening or hemoglobinopathy will not be eligible for the study
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study drug administration
- •History or presence of significant alcoholism or drug abuse in the past one year.
- •HbA1c values (at screening) more than 5.7%
- •Subjects who is 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 of screening visit.
- •Subjects who have received any investigational drug within 30 days of screening visit.
结局指标
主要结局
pharmacokinetic parameters (Cmax and AUC0-24h)
时间窗: pharmacokinetic parameters- 0-24 hrs
pharmacodynamic parameters (AUCGIR,0-24h, and GIRmax)
时间窗: pharmacokinetic parameters- 0-24 hrs
次要结局
- to compare the pharmacokinetic(and pharmacodynamic profile as well as assess safety and local)
研究者
研究点 (1)
Loading locations...
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