NCT07300007尚未招募1 期
An Open-Label, Randomized, Crossover Study to Characterize the Pharmacokinetics and Relative Bioavailability of Liquid Metformin at 100 mg/mL and 250 mg/mL Compared With Standard Metformin Tablets
Aspargo Labs, Inc0 个研究点目标入组 24 人开始时间: 2026年3月15日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The study will evaluate the pharmacokinetics and relative bioavailability of two liquid metformin formulations (100 mg/mL and 250 mg/mL)
详细描述
The study will compare the pharmacokinetic profiles of two liquid metformin formulations (100 mg/mL and 250 mg/mL) with a standard metformin immediate-release tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults 18 to 55 years of age, inclusive.
- •Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.
- •Medically healthy with no clinically significant findings on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests, in the opinion of the investigator.
- •Non-smokers or light smokers (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement.
- •Able to understand and provide written informed consent before any study procedures are conducted.
- •Willing and able to comply with all study requirements, including fasting restrictions and visit schedules.
- •Females of childbearing potential must use acceptable contraception as determined by the investigator.
排除标准
- •Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.
- •History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders that could affect study participation or data interpretation.
- •Estimated glomerular filtration rate (eGFR) less than 90 mL per minute per 1.73 square meters, or any clinically significant abnormal laboratory findings.
- •History of lactic acidosis.
- •Use of prescription medications, over-the-counter medications, herbal supplements, or dietary supplements within 14 days before first dosing, unless approved by the investigator.
- •Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
- •Positive urine drug test or positive alcohol breath test at screening or admission.
- •Participation in another clinical trial or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before first study dose.
- •Blood donation of more than 450 mL or significant blood loss within 8 weeks before first dosing.
- •Pregnant or breastfeeding females.
- •Women of childbearing potential not using acceptable contraception.
- •Any condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
研究组 & 干预措施
Single-Arm Crossover
Experimental
干预措施: Liquid Metformin 100 mg/mL (Drug)
Single-Arm Crossover
Experimental
干预措施: Liquid Metformin 250 mg/mL (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: Up to approximately 24 to 36 hours postdose in each treatment period
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t)
时间窗: Up to approximately 24 to 36 hours postdose in each treatment period
次要结局
未报告次要终点
研究者
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