CTRI/2020/09/027956已完成1 期
An open label, randomized, two-treatment, two-sequence, four-period, single-dose, full replicate crossover bioequivalence study of GEN1501 (Insulin Glargine Injection) 100 U/mL of GeneSys Biologics Pvt. Ltd., Hyderabad, India and LANTUS® (Insulin Glargine Injection) 100 U/mL of Sanofi-Aventis, in healthy male, adult, human subjects under fasting conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- INS-AUC(0-24h), INS-Cmax, Tmax.
研究概览
简要总结
The purpose of this study is to assess and compare the pharmacokinetic and pharmacodynamic properties of GEN1501 with Lantus®
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy human subjects between 18-45 years of age (including both) and weight ≥ 50 Kg (BMI 18.5 to 24.9 kg/m²).
- •Acceptable findings during registration and screening including, medical history, physical examination, laboratory evaluations, 12- lead ECG and Chest X-Ray (postero-anterior view).
- •HbA1c levels <5.7%
- •Normal range for OGTT
- •Values within normal ranges for laboratory parameters upon evaluation by the Investigator or Physician.
- •Subjects able to communicate effectively.
- •Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- •Subject willing to abstain from all kinds of alcoholic beverages, smoking, and caffeine/xanthine containing foods or beverages from 48:00 hours before admission till the last blood sample in each Period.
- •Subjects without any evidence of impaired glucose tolerance in 2:00 hours oral glucose tolerance test.
排除标准
- •Volunteers having a known history of contraindication or hypersensitivity (e.g., anaphylaxis) to Insulin or any of its related group of drugs will be excluded from the study.
- •A history or presence of significant asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological or psychiatric disease/disorder, dermatological, endocrine, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
- •History or presence of gastrointestinal (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine.
- •History or evidence of exfoliative dermatitis, Stevens.
- •Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
- •Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
- •Participation in a drug research study within 90 days prior to dosing of this study.
- •Blood loss or whole blood donation within 90 days prior to drug administration.
- •Consumption of high caffeine (more than 5 cups of coffee or tea/day) or tobacco (more than 9 cigarettes/beedies/cigars per day).
- •History of addiction to any recreational drug or drug dependence.
- •An unusual or abnormal diet, for whatever reason within 48:00 hours prior to admission of each period, e.g. fasting due to religious reasons.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24:00 hours prior to study check-in of each period.
- •Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study check-in of each period.
- •Positive results for alcohol breathe analysis during the study check-in of each period.
- •History of pre-existing bleeding disorder.
- •Difficulty in swallowing solids like tablets or capsules.
- •Difficulty with donating blood.
- •Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
- •Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- •Pulse rate less than 60 beats/minute or more than 100 beats/minute.
- •Use of any prescribed medication or OTC medicinal products during last two weeks preceding the first dosing.
- •History of alcohol abuse and/or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to dosing of this study.
结局指标
主要结局
INS-AUC(0-24h), INS-Cmax, Tmax.
时间窗: 0-24 hours
次要结局
- GIR-AUC(0-24h), GIRmax, TGIRmax(0-24 hours)
研究者
研究点 (1)
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