A randomized, double blinded, balanced, two treatment, two period, two sequence, cross over, euglycemic clamp study to compare the pharmacokinetic and pharmacodynamic activity of RapilinTM 30 (30% insulin aspart and 70% insulin aspart protamine suspension) injection with NovoMix® 30 (30% insulin aspart and 70% insulin aspart protamine suspension) after single dose subcutaneous injection in healthy human adult male subjects under fasting condition.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Comparative Bioavalability of test and reference product
研究概览
简要总结
A randomized, double blinded, balanced, two treatment, two period, two sequence, cross over, euglycemic clamp study to compare the pharmacokinetic and pharmacodynamic activity of Insulin under fasting condition.4.1. Primary ObjectiveThe primary objective of this study is to • To assess the pharmacokinetics profile of RapilinTM 30 (30% insulin aspart and 70% insulin aspart protamine suspension) injection with NovoMix® 30 (30% insulin aspart and 70% insulin aspart protamine suspension) of Novo Nordisk, India after single dose subcutaneous injection in healthy human adult male subjects under fasting condition.• To assess the pharmacodynamics profile of RapilinTM 30 (30% insulin aspart and 70% insulin aspart protamine suspension) injection with NovoMix® 30 (30% insulin aspart and 70% insulin aspart protamine suspension) of Novo Nordisk, India after single dose subcutaneous injection in healthy human adult male subjects under fasting conditions using Euglycemic clamp technique by means of Glucose Infusion Rate (GIR). The GIR time profile reflects the pharmacodynamics time action profile of administered insulin in healthy human adult male subjects under fasting condition.4.2. Secondary ObjectiveThe secondary objective of this study is to monitor the safety and tolerability of a single dose subcutaneous injection of RapilinTM 30 or NovoMix® 30 when administered in healthy human adult male subjects under fasting condition.4.3. Study RationaleThis study is being conducted to compare the pharmacokinetic and pharmacodynamic activity of RapilinTM 30 (30% insulin aspart and 70% insulin aspart protamine suspension) injection with NovoMix® 30 (30% insulin aspart and 70% insulin aspart protamine suspension) of Novo Nordisk, India after single dose subcutaneous injection in healthy human adult male subjects under fasting condition Bioequivalence CriteriaPharmacokinetic ParameterBased on the 90% confidence intervals for the difference of means of ln-transformed AUC0-24 and Cmax will be drawn whether the test product is bioequivalent to the reference product under fasting condition. The acceptance range for bioequivalence is 80.00-125.00% for the 90% confidence intervals for the difference of means of lntransformed AUC0-24 and Cmax with respect to Insulin.For Pharmacodynamic Parameters:Based on the 95% confidence intervals for the difference of means of ln-transformed GIR-AUC0-24 and GIRmax conclusions will be drawn whether the test product is bioequivalent to the reference product under fasting conditions. The acceptance range for bioequivalence is 75.00-133.00% for the 95% confidence intervals for the difference of means of ln-transformed GIR-AUC0-24 and GIRmax with respect to Glucose Infusion Rate.
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
- All
入选标准
- •Normal healthy human adult male volunteers aged between 18 -45 years (both ages inclusive).
- •Volunteer provided written informed consent and are willing to participate in the study.
- •Volunteer with Body Mass Index of 18.50 to 27.00 Kg/m2 (both inclusive).
- •No evidence of underlying disease during pre-study screening, medical history, physical examination and laboratory investigations done within 21 days prior to commencement of the study.
- •Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study.
- •Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR.
- •Negative test results for alcohol (in urine or in breath), negative urine drugs of abuse test.
- •Non-smoker, non-tobacco (in any form) users;
- •12 lead ECG recording either normal or within acceptable limits or considered by the Investigator to be of no clinical significance with respect to his participation in the study.
- •Normal or clinically non.
- •significant chest X-ray (PA) taken within 06 months before the day of dosing.
- •Available for the entire study and capable of understanding instructions and communicating with the investigators and clinical study facility staff.
- •Who has not undergone vasectomy, must agree to use condoms, or spermicide to avoid fathering a child during the course of the study and for a period of 07 days after the last dose administration of investigational product.
- •Volunteer having Oral Glucose Tolerance Test (OGTT) results showing within normal or within acceptable limits or as considered by the Investigator to be of no clinical significance with respect to his participation in the study.
- •Volunteer having HbA1c: less than or equal to 5.6%.
排除标准
- •Known allergy to Insulin or any component of the formulation and to any other related drug.
- •History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •History/presence of alcohol abuse or drug abuse.
- •History of smoking, even single cigarette, bidis or any other form.
- •History/presence of asthma.
- •History/presence of urticaria or other allergic type reactions after taking any medication.
- •History/presence of clinically significant illness within 04 weeks before the start of the study.
- •History/presence of significant Hypersensitivity to heparin.
- •History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs.
- •Scheduled for surgery any time during study or within 07 days after study completion.
- •History of difficulty in donating blood.
- •With unsuitable veins for repeated venipuncture.
- •Participation in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days.
- •Consumption of prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing in Period 1, including topical medication.
- •Hospitalization within 28 days prior to administration of the study medication.
- •History of difficulty in swallowing.
- •Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial.
- •With Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.
- •With Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator.
- •Use of any insulin product in the past.
结局指标
主要结局
Comparative Bioavalability of test and reference product
时间窗: 8 weeks
次要结局
- The secondary objective of this study is to monitor the safety and tolerability of a single(dose subcutaneous injection of RapilinTM 30 or NovoMix® 30 when administered in)