NCT07300059尚未招募1 期
Short-Term Glycemic Effects of Two Concentrations of Liquid Metformin Versus Standard Metformin Tablets in Healthy Adults
Aspargo Labs, Inc0 个研究点目标入组 24 人开始时间: 2026年7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
- Area Under the Blood Glucose-Time Curve from 0 to 4 Hours Postdose (Glucose AUC₀-₄h)
研究概览
简要总结
This is an open-label, randomized study evaluating the short-term glycemic effects of two concentrations of liquid metformin formulations (100 mg/mL and 250 mg/mL) compared with standard immediate-release metformin tablets in healthy adult subjects. Participants will receive single or short-term doses of study treatments in a randomized sequence. Blood glucose measurements and other glycemic indicators will be collected to assess short-term pharmacodynamic effects. Safety and tolerability will also be monitored.
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 based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.
- •Fasting blood glucose within the normal reference range at screening.
- •Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during each study confinement period.
- •Able to understand and provide written informed consent before participation.
- •Willing and able to comply with all study procedures, including fasting requirements, glycemic assessments, and timed blood draws.
- •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 any clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric condition that, in the investigator's judgment, could interfere with study participation or data interpretation.
- •Fasting blood glucose outside the normal reference range at screening, or any history of hypoglycemia or glucose regulation disorders.
- •Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m² or any clinically significant abnormal clinical laboratory results.
- •History of lactic acidosis.
- •Use of prescription medications, over-the-counter medications, vitamins, herbal supplements, or dietary supplements within 14 days before first study dosing, unless approved by the investigator.
- •Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
- •Positive urine drug screen or positive alcohol breath test at screening or admission.
- •Participation in another clinical study or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before the first study dose.
- •Donation of ≥450 mL of blood, or significant blood loss, within 8 weeks before the first study dose.
- •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)
Single-Arm Crossover
Experimental
干预措施: Standard Metformin Immediate-Release Tablet (Drug)
结局指标
主要结局
Area Under the Blood Glucose-Time Curve from 0 to 4 Hours Postdose (Glucose AUC₀-₄h)
时间窗: 0 to 4 hours after each study dose in each treatment period
次要结局
未报告次要终点
研究者
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