CTRI/2025/09/094225尚未招募不适用
A double blind, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover, pharmacokinetic and pharmacodynamic bioequivalence study of insulin degludec and insulin aspart injection 100 units/mL of G. C Chemie Pharmie Limited, India comparing with Ryzodeg (Insulin degludec/Insulin aspart) 100 units/mL of Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark, in healthy, adult, human male subjects using Euglycemic clamp technique under fasting conditions.
G. C. Chemie Pharmie Ltd1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年10月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Primary PK Parameter:
研究概览
简要总结
A double blind, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover, pharmacokinetic and pharmacodynamic bioequivalence study of insulin degludec and insulin aspart injection 100 units/mL of G. C Chemie Pharmie Limited, India comparing with Ryzodeg (Insulin degludec/Insulin aspart) 100 units/mL of Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark, in healthy, adult, human male subjects using Euglycemic clamp technique under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Subjects who are able to communicate effectively.
- •Normal range for OGTT.
- •Truly voluntary participation.
- •Subjects willing to adhere to the protocol requirements and capable to provide written informed consent and able to comprehend and be informed of the nature of the study.
- •5 Body mass index in the range of 18.5 to 24.9 weight should be greater than equals to 50 Kg.
- •HbA1c less than 5.7 percent.
- •Normal 12 lead ECG.
- •Normal chest X ray.
- •Normal laboratory parameters 10.Absence of disease markers of HIV 1 and 2 hepatitis B and C virus and VDRL 11.Subject willing to abstain from all kinds of alcoholic beverages smoking or chewing tobacco pan or pan masala gutkha masala containing betel nut and tobacco, having caffeine or xanthine containing foods or beverages like chocolate tea coffee or cola drinks from 72.00 hours prior to period 01 admission until the last 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 Parameter:
时间窗: 0-120 Hrs
INS-AUC0-t, INS-AUC0-inf, and Cmax
时间窗: 0-120 Hrs
Primary PD Parameter:
时间窗: 0-120 Hrs
GIR-AUC0-24 and GIRmax
时间窗: 0-120 Hrs
次要结局
- Secondary PK Parameter:(Tmax , t1/2 & Kel)
研究者
DrSowmya Bondalapati
ADVITY Research Pvt. Ltd.
研究点 (1)
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