NCT00772265已完成1 期
A Randomized Single Center Double Blind 2 Period Crossover Glucose Clamp Study to Test for Bioequivalence Between 2 Recombinant Human Isophane Insulins Wockhardt's Human Isophane Insulin Injection100IU/ml With Novolin N in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Mean AUC0-24h and Cmax
研究概览
简要总结
The aim of this trial is to demonstrate bioequivalence of Wosulin N to Novolin® N with regard to its total and to its maximum serum insulin concentrations.
详细描述
The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between Wosulin N and Novolin® N.The study also compares the pharmacokinetic and pharmacodynamic profiles as well as assessing safety and local tolerability of the two insulin preparations in healthy subjects.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subject.
- •Age more than 18 and less than 45 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 intention of becoming pregnant or not using adequate contraceptive measures (defined as intrauterine device (IUD) that has been in place for at least 3 months, double barrier contraception, sterilization or abstinence, or oral contraceptive pill, which should have been taken without difficulty for at least 3 months, or an approved hormonal implant).
- •Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator. In particular, subjects with 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 of normal) will not be allowed to enter the trial.
- •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 (haemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
- •History of alcohol or drug abuse in the past five years and/or any positive test for drugs of abuse at screening.
- •Any positive reaction of 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 any insulin product for therapeutic purposes in the past.
- •Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of acetaminophen is permitted.
- •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.
结局指标
主要结局
Mean AUC0-24h and Cmax
时间窗: Visit 2 and 3
次要结局
- PK endpts: AUC0-4h, AUC0-6h, AUC0-12h, AUC6-12h, AUC6-24h,tmax,and elimination rate constant. PD endpoints: AUCGIR0-4h, AUCGIR0-6h, AUCGIR0-12h,AUCGIR0-24h, AUCGIR6-12h, AUCGIR6-24h, GIRmax and tGIRmax Safety : AEs,haematology,biochem,phy exam.(Visit 2,3 and 4)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
ow level laser treatment for women showing signs and symptoms of capsular contracture following implant-based breast reconstruction for breast cancer (LaTCon study)Capsular ContractureCancer - BreastBreast CancerACTRN12615000629538Breast & Surgical Oncology at The Poche Centre40
已完成
3 期
Study of the Commercial Scale SARS-CoV-2 Vaccine Against the Pilot Scale Among Adults, and Bridging Study of the Immunogenicity in Elderly Against That in AdultsCovid19NCT04617483Sinovac Research and Development Co., Ltd.1,040
进行中（未招募）
1 期
Efficacy and Safety of apraglutide in steroid refractory gastrointestinal acute graft versus host diseaseAcute graft versus host disease (GVHD)MedDRA version: 20.0Level: PTClassification code 10075160Term: Graft versus host disease in gastrointestinal tractSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.0Level: LLTClassification code 10075161Term: Graft versus host disease in GI tractSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10066264Term: Acute graft versus host disease in intestineSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10066260Term: Acute graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersEUCTR2021-004588-29-ESVectivBio AG34
已完成
不适用
Double-blind crossover trial to evaluate the efficacy and safety of the bath additive containing combination of sweat-antigen-inactivating and moisturizing ingredients for atopic dermatitis 2 (Examination of the seasonal influence)atopic dermatitisJPRN-UMIN000028635Hiroshima Umiversity Hospital5
已完成
不适用
Double-blind crossover trial to evaluate the efficacy and safety of the bath additive containing combination of sweat-antigen-inactivating and moisturizing ingredients for atopic dermatitisatopic dermatitisJPRN-UMIN000026182Hiroshima Umiversity Hospital34