NCT02342925已完成1 期
A Study of the Effect of RG1662 on Metformin in Healthy Volunteers
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
- 17
- 主要终点
- Pharmacokinetic parameters of metformin derived from plasma and urine concentrations of metformin: area under the concentration-time curve (AUC), maximum concentration (Cmax), renal clearance (CLr) [composite outcome measure]
研究概览
简要总结
This single-center, non-randomized, open-label, two treatment, two period, fixed sequence crossover study will investigate the effect of RG1662 treatment on the activity of key renal transporters in healthy male and female participants using metformin. The effect of RG1662 on other renal function parameters will also be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants, aged 18 to 60 years, inclusive
- •A body mass index between 18 to 32 kg/m2, inclusive
- •Informed consent and agreement to comply with study restrictions
排除标准
- •A history of epilepsy, convulsions or significant head injury
- •Significant history of drug allergy or a known hypersensitivity to any of the ingredients of any of the study treatments
- •Pregnant or lactating
- •Impaired renal function or clinically relevant hematuria
- •A history of lactic acidosis, or risk factors for lactic acidosis
- •Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
研究组 & 干预措施
RG1662 plus metformin
Experimental
干预措施: Omnipaque 300 (Other)
RG1662 plus metformin
Experimental
干预措施: RG1662 (Drug)
RG1662 plus metformin
Experimental
干预措施: metformin (Drug)
metformin alone
Experimental
干预措施: Omnipaque 300 (Other)
metformin alone
Experimental
干预措施: metformin (Drug)
结局指标
主要结局
Pharmacokinetic parameters of metformin derived from plasma and urine concentrations of metformin: area under the concentration-time curve (AUC), maximum concentration (Cmax), renal clearance (CLr) [composite outcome measure]
时间窗: Up to 9 weeks
次要结局
- Pharmacodynamics: renal function measured by derivation of glomerular filtration rate (GFR) from plasma concentrations of iohexol.(Up to 9 weeks)
- Pharmacokinetic parameters derived from plasma concentrations of RG1662: AUC, Cmax, time to maximum concentration (Tmax), and minimum concentration (Ctrough)[composite outcome measure](Up to 9 weeks)
- Incidence of adverse events (AEs)(Up to 9 weeks)
研究者
相似试验
招募中
2 期
Study of effect of metformin in patients with relapsed epithelial ovarian cancerCTRI/2015/12/006454Cancer Institute WIA25
已完成
不适用
Effect of Metformin on the esRAGE levels in type 2 diabetic patients: the Metformin Sitagliptin Randomized TrialType 2 DiabetesJPRN-UMIN000005253Osaka City University Graduate School of Medicine, Metabolism, Endocrinology, and Molecular Medicine60
已完成
1 期
Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and RosuvastatinDiabetesHyperlipidemiaNCT02186483Jeil Pharmaceutical Co., Ltd.24
已完成
1 期
Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin CalciumDiabetes MellitusNCT01775579Hanmi Pharmaceutical Company Limited36
已完成
3 期
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is InappropriateDiabetes Mellitus, Type 2NCT00740051Boehringer Ingelheim227