NCT01235039已完成1 期
A Single Center, Double Blind, Randomized Crossover Study Evaluating the Bioequivalence of VIAject®7 Compared to VIAject®25 and Comparing the Pharmacokinetic and Pharmacodynamic Properties of VIAject®7 to Insulin Lispro in Subjects With Type 1 Diabetes Mellitus
Biodel1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Serum insulin concentration
研究概览
简要总结
The primary objective of this study is to test for bioequivalence of VIAject®7 and VIAject®25 and to compare the pharmacokinetic/Pharmacodynamic/tolerability characteristics of VIAject®7 with those of VIAject®25 and insulin lispro.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥19 to ≤65 years
- •Body Mass Index: ≥18 - ≤28 kg/m2
- •Diagnosed with Type 1 Diabetes Mellitus for at least 1 year
- •Insulin antibody less than or equal to 10 µU/mL at screening
- •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
- •Type 2 Diabetes Mellitus
- •C-peptide value of >1.0 ng/mL
- •HbA1c value of > 10.0%
- •History of hypersensitivity to any of the components in the study medication
- •History of severe or multiple allergies
- •Treatment with any other investigational drug in the last 3 months before study entry
- •Any systemic treatment with drugs known to interfere with glucose metabolism such as systemic corticoids, non-selective beta-blockers, and monoamine oxidase (MAO) inhibitors within 3 months prior to randomization.
- •Changes (type of drug or dose) in concomitant medication other than insulin or insulin analogues in the last 3 weeks prior to randomization.
- •Use of non-prescription drugs, except routine vitamins, within 3 weeks prior to the first dose of the test drug. Occasional use of paracetamol/acetaminophen is permitted.
- •Progressive disease likely to prove fatal (e.g. malignancies)
- •Current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the Investigator will impair subject safety or protocol compliance
- •Significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the Investigator
- •Clinically significant abnormal hematology 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 (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 study 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 a 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.
- •Blood donation within the last 30 days
- •A woman who is lactating
- •Pregnant women or women intending to become pregnant during the study
- •A sexually active woman - not using adequate contraceptive methods (adequate contraceptive measures include: implants, injectables, combined oral contraceptives, hormonal intrauterine device [IUD], sexual abstinence or vasectomized partner)
- •Positive serology for HIV, Hepatitis B or Hepatitis C
- •Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the Investigator
- •Lack of compliance or other reasons which, in the opinion of the Investigator, prevent the participation of the subject in the study.
研究组 & 干预措施
Formulation A
Experimental
VIAject®25 for subcutaneous application
干预措施: VIAject®25 (Drug)
Formulation B
Experimental
VIAject®7 for subcutaneous application
干预措施: VIAject®7 (Drug)
Formulation C
Experimental
Insulin Lispro for subcutaneous application
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Serum insulin concentration
时间窗: 0-480 minutes
Area under the serum insulin concentration curve for the time interval 0-480 min (AUC-INS 0-480) and maximum serum insulin concentration (C-INS max) (VIAject®7and VIAject®25 only)
次要结局
- Serum insulin concentration(0-240 minutes)
- Glucose infusion rate(Between 0-240 minutes and 0-480 minutes)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical Study on the Bioequivalence of Vitamin D in Healthy AdultsBioequivalence of Vitamin D in Healthy AdultsNCT03552666Church & Dwight Company, Inc.9
已完成
3 期
Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia BHemophilia BNCT00093210Wyeth is now a wholly owned subsidiary of Pfizer
尚未招募
1 期
Bioequivalence Study of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible TabletFastingNCT06522763Swiss Pharma Nigeria Limited46
已完成
1 期
A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial ManufacturersHealthyNCT02171208Biogen80
已完成
不适用
Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90mcg Per Actuation in Healthy Volunteers Under Fasting ConditionsHealthyNCT05300087Intech Biopharm Ltd.60