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临床试验/NCT01560481
NCT01560481已完成1 期

Randomized Clinical Trial to Evaluate Safety, Tolerability and PK-PD Profile of Metformin Glycinate 620 mg,1240 mg, 2480 mg and Metformin Chlorhydrate 1000 mg of One Single Dose, Multiple Dose and After Food Intake.

Laboratorios Silanes S.A. de C.V.2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2011年12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
入组人数
49
试验地点
2
主要终点
Step A: Number of Adverse Events of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose

研究概览

简要总结

Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes.

The objective of this study is to evaluate the safety, tolerability and pK profile of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose, in step A. In step A will be included 25 volunteers.

In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be included 24 volunteers.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 45 years.
  • Weight within normal ranges (Quetelet index between 21 and 26) (weight (kg)/height (m2).
  • Adequate physical examination and clinical history
  • No organic and psychiatric disorder
  • Normal Blood pressure, Pulse Rate, temperature and ECG.
  • Lab test within normal values according to reference lab values of Biochemistry lab of Hospital Santa Creu I Sant Pau. It will be allowed changes according to clinical criteria of the clinical staff of ICIM-SANT PAU
  • Females of childbearing potential with adequate contraceptive precautions, other than oral contraceptives and negative urine pregnancy test.
  • No participation in any other clinical trial within the previous two months before the initiation of this study.
  • No blood donation within the previous four weeks before the initiation of this study.
  • Signed informed consent.

排除标准

  • Drugs or alcohol abuse.
  • Consumer of stimulant drinks (> 5 coffees, teas, cola drinks).
  • Smokers (> 10 cigars).
  • Precedents of drugs allergy or hypersensitivity
  • Intake of any other medication within the previous 15 days before this study.
  • Positive HIV, HBV or HCV.
  • Chronic disease (cardiovascular, respiratory, endocrine, gastrointestinal, hematologic, neurologic or others).
  • Prior surgery within the previous six months before the initiation of this study.
  • Pregnant women or breastfeeding or females of childbearing potential with no adequate contraceptive precautions, other than oral contraceptives.

研究组 & 干预措施

Step A: metformin glycinate 620 mg

Experimental

620mg single dose by mouth

干预措施: Step A: metformin glycinate 620 mg single dose (Drug)

Step A: metformin glycinate 1240 mg

Experimental

1240mg single dose by mouth

干预措施: Step A: metformin glycinate 1240 mg single dose (Drug)

Step A: metformin glycinate 2480 mg

Experimental

2480mg single dose by mouth

干预措施: Step A: metformin glycinate 2480 mg single dose (Drug)

Step A: metformin hydrochloride 1000 mg

Active Comparator

1000mg single dose by mouth

干预措施: Step A: metformin hydrochloride 1000 mg single dose (Drug)

Step A: metformin glycinate 1240 mg, food intake

Experimental

1240mg single dose by mouth after food intake

干预措施: Step A: metformin glycinate 1240 mg,food intake (Drug)

Step B: metformin glycinate 620 mg BID

Experimental

620mg BID for 8 days

干预措施: Step B: metformin glycinate 620 mg BID (Drug)

Step B: metformin hydrochloride 500 mg BID

Active Comparator

500mg tablets BID for 8 days

干预措施: Step B: metformin hydrochloride 500 mg BID (Drug)

结局指标

主要结局

Step A: Number of Adverse Events of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose

时间窗: 35 days

Tolerability: * adverse events, * systolic and diastolic blood pressure, pulse rate and temperature * pulse rate and ECG alterations * alterations in haematology, plasma chemistry, and urine analyses

Step B: Number of Adverse Events of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days

时间窗: 25 days

Tolerability: * adverse events, * systolic and diastolic blood pressure, pulse rate and temperature * pulse rate and ECG alterations * alterations in haematology, plasma chemistry, and urine analyses

次要结局

  • Step A: Bioavailability (Cmax) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast(36 hours)
  • Step A: Bioavailability (AUC) of metformin glycinate 1240 mg QD in fasted subjects and after the intake of fat rich breakfast(36 hours)
  • Step A: Bioavailability (AUC) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD.(36 hours)
  • Step A: Linear and dose-proportional (AUC) pharmacokinetic of 620 mg, 1240 mg and 2480 strengths of metformin glycinate(36 hours)
  • Step A: Pharmacokinetic profile (AUC) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD.(36 hours)
  • Step B: Bioavailability (AUC) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days.(8 days)
  • Step A: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg QD, 1240 mg QD, 2480 mg QD after administration one single dose and pharmacokinetic profile of metformin chlorhydrate 1000mg QD.(36 hours)
  • Step B: Bioavailability (Cmax) of metformin glycinate 620 mg BID and bioavailability of metformin chlorhydrate 500mg BID, after administration of multiple doses during 8 days.(8 days)
  • Step B: Pharmacokinetic profile (Cmax) of metformin glycinate 620mg BID after administration of multiple doses during 8 days(8 days)
  • Step B: Pharmacokinetic profile (AUC) of metformin glycinate 620mg BID after administration of multiple doses during 8 days(8 days)
  • Step A: Bioavailability (Cmax) of metformin glycinate 620 mg QD, 1240 mg QD, 2480 mg QD after administration of one single dose with metformin Chlorhydrate 1000 mg QD.(36 hours)
  • Step A: Linear and dose-proportional pharmacokinetic (Cmax) of 620 mg, 1240 mg and 2480 strengths of metformin glycinate(36 hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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