NCT03555305已完成1 期
Relative Bioavailability of LY2963016 to LANTUS® After Single-Dose Subcutaneous Administration in Healthy Chinese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus
研究概览
简要总结
The purpose of this study is to compare a study drug known as Insulin glargine with Lantus in healthy Chinese participants. Blood samples will be taken to compare how the body handles the drugs and how they affect blood sugar levels. Side effects and tolerability will be documented. The study will last at least 18 days, not including screening. Screening is required within 4 weeks prior to the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are native Chinese men or women. Native Chinese is defined as a participant who has both parents and all 4 grandparents of Chinese origin.
- •For females of childbearing potential (defined as not surgically sterilised and between menarche and 1-year postmenopause) only:
- •Negative serum pregnancy test at the time of screening.
- •Are not lactating.
- •Intend not to become pregnant during the study.
- •Are sexually inactive or have practiced a reliable method of birth control for at least 6 weeks prior to screening.
- •Agree to continue to use a reliable method of birth control (as determined by the investigator) during the study.
- •For females not of childbearing potential, must be:
- •Surgically sterile, defined as having had a hysterectomy or bilateral oophorectomy or tubal ligation, and/or
- •Menopausal, defined as having had no menses for at least 1 year, or a plasma follicular stimulating hormone value of >40 milli-international units per milliliter (mIU/mL) and no menses for at least 6 months, unless the participant is taking hormone-replacement therapy.
- •Having fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.1 millimoles per liter [mmol/L]) and 2-hour glucose level <140 mg/dL (<7.8 mmol/L) on the 75 grams (g) oral glucose tolerance test.
- •Have a body mass index (BMI) between 18 and 28 kilograms per meter squared (kg/m²), inclusive, at screening.
- •Are nonsmokers, have not smoked for at least 6 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study.
- •Have normal blood pressure and pulse rate at screening, as determined by the investigator.
- •Have an electrocardiogram (ECG), at screening, considered as within normal limits by the investigator.
- •Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
排除标准
- •Have a history of first-degree relatives known to have diabetes mellitus.
- •Have known allergies to insulin glargine or its excipients, or related drugs, or heparin, or have a history of relevant allergic reactions of any origin.
- •Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
- •Show evidence of human immunodeficiency virus infection (HIV) and/or positive human HIV antibodies.
- •Have positive hepatitis B surface antigen.
- •Have donated >400 mL of blood in the last 6 months or donated >100 mL within the last 30 days.
- •Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to stop alcohol consumption while resident in the clinical research unit (CRU) (1 unit = 12 ounces or 360 mL of beer; 5 ounces or 150 mL of wine; 1.5 ounces or 45 mL of distilled spirits).
- •Intend to use: prescription medication or over-the-counter medication or Chinese traditional medicine within 14 days before dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement, or birth control methods). If this situation arises, an otherwise suitable participant may be included at the discretion of the investigator.
研究组 & 干预措施
Insulin Glargine
Experimental
Participants received 0.5 units per kilogram (U/kg) of Insulin Glargine subcutaneously (SC).
干预措施: Insulin Glargine (Drug)
Lantus
Active Comparator
Participants received 0.5 U/Kg of Lantus subcutaneously.
干预措施: Lantus (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus
时间窗: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin glargine and Lantus.
PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Insulin Glargine and Lantus
时间窗: -0.5 and 0 hours predose; 0.5, 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24 hours postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC\[0-24\]) of Insulin glargine and Lantus.
次要结局
- Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)(30 minutes predose through 24 hours postdose)
- PD: Maximum Glucose Infusion Rate (Rmax)(30 minutes predose through 24 hours postdose)
研究者
研究点 (1)
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