IRCT201203227978N2已完成4 期
In healthy human volunteers; study ?of Insulin Glargine (Basagine™) after single ?subcutaneous injection of 0.2 unit/Kg dose; compared with nothing ?and primarily to establish the PK parameters Cmax, ?Tmax and AUC in Pakistani population.?
Getz Pharma (Pvt) Limited0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 50 years（—）
- 性别
- Male
入选标准
- •INCLUSION: Healthy male/female, Age:18 to 50 years, BMI: 18-26 Kg/m2, Fasting plasma glucose: <6.0 mmol/l (<108 mg/dl) or normal range and Non-smoker, non-alcoholic
- •EXCLUSION: • Volunteers with any neuropathy, diabetes mellitus. • Any active allergic disease or a history of significant allergic disease. • Presence of renal, hepatic or gastrointestinal disease known to interfere with the drug absorption, distribution, metabolism or elimination with in last year. • Subject demonstrates protocol non-compliance (e.g. uncooperative attitude, & inability to finish study). • Participation in another study within last 2 months of 1st drug administration. • If donated blood within last 2 months preceding the study. • Age below 18 years and above 50yr. • Smoking within last 3 months prior to the drug administration and 6 hours after drug administration. • Ingestion of OTC drug (except Paracetamol) within last 14 days of 1st drug administration. • Participants with insufficient organ and/or bone marrow dysfunction. • Ingestion of investigational drug within 1 year prior to 1st drug administration. • Participants with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF) that places the patient at risk by participating in the study. • Results of CBC, LFT, serum creatinine, fasting plasma glucose indicating significantly out of range and abnormal ECG. • Participants with any physical/mental disability • Subjects with known HIV, hepatitis B or hepatitis C infection, or autoimmune diseases. • History of major organ transplantation, new onset diabetes, unstable thyroid function. • Alcohol or drug abuse within the past year. • Known hypersensitivity to investigational drug • Positive drug of abuse test and alcohol test. • Intake of gutka, pan and any other thing containing nicotine 48 hours before and during study.
排除标准
- 未提供
研究者
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