CTRI/2022/11/047188已完成1 期
A double blind, balanced, randomized, two-treatment, two-sequence, two-period, single dose, cross over, pharmacokinetic and pharmacodynamic bioequivalence study of GEN1503PR (Insulin Aspart (r-DNA origin) Injection) 100 U/mL of GeneSys Biologics Pvt. Ltd. Hyderabad, India and NovoRapid® (Insulin Aspart (r-DNA origin) Injection) 100 U/mL of Novo Nordisk, in healthy adult, male human subjects using Euglycemic clamp technique under fasting conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Primary PK Parameters:
研究概览
简要总结
The purpose of this study is to assess and compare the pharmacokinetic and pharmacodynamic properties of GEN1503PR with NovoRapid®
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Healthy human subjects between 18-45 years of age.
- •Subjects able to communicate effectively.
- •Normal range for OGTT.
- •Truly voluntarily participation.
- •Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- •Body mass index in the range of 18.5 to 24.9 kg/m2 (weight should be ≥ 50 Kg).
- •Normal 12-lead ECG
- •Normal chest X-ray
- •Absence of disease markers of HIV 1 & 2, hepatitis B & C virus and VDRL
- •Subject willing to abstain from all kinds of alcoholic beverages, smoking, and caffeine/xanthine containing foods or beverages from 72.00 hours before admission till the last post-dose blood sample collection in each study period.
排除标准
- •Subjects having history of contraindication or hypersensitivity (e.g., anaphylaxis) to Insulin or related class 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.
- •History or presence of diabetes, migraine, hypertension, cardiovascular, pulmonary, 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 presence of significant systemic diseases, seizures, psychiatric disorders, neurological disorders.
- •History of diabetic ketoacidosis
- •History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting)
- •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 48.00 hours prior to study admission of each period.
- •Positive results for drugs of abuse (benzodiazepines, cocaines, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of each study period.
- •Positive results for alcohol consumption during the admission of each study period.
- •History of pre-existing bleeding disorder.
- •Difficulty with donating blood.
- •Difficulty in swallowing oral solids like tablets / capsules.
- •Blood pressure on the day of admission of each study period a. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg. b. 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 on the day of admission of each study period.
- •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
Primary PK Parameters:
时间窗: 0-12 hrs
INS-AUC0-t, INS-AUC0-inf, Cmax
时间窗: 0-12 hrs
Primary PD Parameters:
时间窗: 0-12 hrs
GIR-AUC0-12 and GIRmax
时间窗: 0-12 hrs
次要结局
- Secondary PK Parameters:(Tmax , t1/2 and Kel)
研究者
研究点 (1)
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