NCT01399255撤回1 期
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Lispro (Listro™) With Humalog® in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Wockhardt
- 试验地点
- 2
- 主要终点
- Bioequivalence based on Pharmacokinetic parameter AUC (INS-LIS 0-8h)
研究概览
简要总结
The aim of this study is to assess the bioequivalence of two rapid-acting insulin Lispro formulations: Humalog® and Listro™ in healthy subjects based on the pharmacokinetic parameter (PK) and the pharmacodynamic parameter (PD).
详细描述
The purpose of this study is to assess the bioequivalence of two rapid-acting insulin Lispro formulations: Humalog® and Listro™ in healthy subjects, based on the pharmacokinetic parameter (PK) AUC (INS-LIS 0-8h) and the pharmacodynamic parameter (PD) AUC (GIR 0-8h) and also assess the safety and local tolerability of the two insulin preparations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects.
- •Age ≥18 and ≤50 years.
- •Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- •Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, inclusive.
- •Non-smoker, defined as no nicotine consumption for at least one year.
- •Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
排除标准
- •Previous participation in this trial or other clinical trials within the last 30 days.
- •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (e.g. intrauterine device (IUD) that has been in place for at least 3 months, or sterilization, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant or double barrier method) including male condoms used plus spermicide, diaphragm with spermicide plus male condom cap with spermicide plus male condom are acceptable options).
- •Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with an elevated fasting blood glucose, elevated liver enzymes (AST or ALT >2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit will not be allowed to enter the trial. Subjects with abnormal TSH may be required to have additional testing of thyroid hormones for further clarification. Subjects with abnormal TSH judged by the Investigator as clinically significant will be excluded from the study.
- •Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
- •History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- •Cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time.
- •Clinically significant abnormal ECG at screening, as judged by the Investigator.
- •History of alcohol or drug abuse in the past five years.
- •Any positive screen for drugs of abuse.
- •Hepatitis B or C or HIV positive.
- •Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
- •Use of non-prescription drugs, except routine vitamins or herbal products, within 3 weeks prior to the first dose of the test drug.
- •Occasional use of acetaminophen is permitted. Acetaminophen is not allowed on the dosing day until 4 hours postdosing.
- •Use of systemic corticosteroids, monoamine oxidase (MAO) inhibitors, prostaglandin blockers, systemic non-selective beta-blockers, growth hormones
- •Thyroid hormones are not allowed unless stable during the past 3 months.
- •Any use of non-steroid anti-inflammatory drugs (NSAIDs) except for low-dose Aspirin is not allowed within 7 days prior to dosing and on the dosing day.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
- •Blood donation of more than 500 ml within the last 12 weeks.
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- •Known or suspected allergy to trial product or related products.
- •History of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children) as judged by the Investigator.
- •Any disease or condition that, in the opinion of the Investigator, would represent an unacceptable risk for the subject's safety.
结局指标
主要结局
Bioequivalence based on Pharmacokinetic parameter AUC (INS-LIS 0-8h)
时间窗: 8 hrs post dose
Glucose clamp will be terminated 10 hours post dose and the primary pharmacokinetic bioequivalance will be calculated based on the Area under the curve (AUC) between 0 - 8 hours postdose of the study medication.
Bioequivalence based on Pharmacodynamic parameter: AUC (GIR 0-8h)
时间窗: 8 hrs post dose
Glucose clamp will be terminated 10 hours post dose and the primary pharmacodymanic bioequivalance will be calculated based on the Area under the curve (AUC) for the glucose infusion rate (GIR) between 0 - 8 hours postdose of the study medication
次要结局
- Pharmacokinetic parameters:Maximum concentration (Cmax)(over 10 hrs post dose)
- Pharmacodynamic parameters: Area under curve glucose infusion rate from 0-10hrs(over 10 hrs post dose)
- Safety endpoints(over 10 hrs post dose)
- Pharmacokinetic parameter: Area under curve from 0-10hrs(over 10 hours postdose)
- Pharmacokinetic Parameters: tmax and t1/2(Over 10 hours postdose)
- Pharmacodynamic parameter: GIR max and tGIR max(over 10 hrs postdose)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
1 期
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Listro Mix 50/50® and Humalog Mix50/50® in Healthy SubjectsBioequivalence in Healthy SubjectsNCT01400789Wockhardt
撤回
1 期
Comparative Bioequivalence Study of Wockhardt's Insulin Analogue Mixture Listro Mix 75/25® and Humalog Mix75/25 ® in Healthy SubjectsBioequivalence in Healthy SubjectsNCT01400802Wockhardt
已完成
1 期
Bioequivalence of Two Lispro FormulationsHealthy VolunteersNCT01133392Eli Lilly and Company41
已完成
1 期
A Study of 2 Different Formulations of Insulin Lispro in Healthy ParticipantsHealthy VolunteersNCT02111083Eli Lilly and Company38
已完成
1 期
Study to Compare 2 Formulations of LY900014 in Healthy ParticipantsHealthyNCT03616977Eli Lilly and Company69