A Randomized Study to Assess the Tolerability Profile of Two Concentrations of Liquid Metformin (100 mg/mL and 250 mg/mL) Compared With Standard Metformin Tablets
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
- Incidence of Gastrointestinal Treatment-Emergent Adverse Events (GI TEAEs)
研究概览
简要总结
This is an open-label, randomized study evaluating the tolerability 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. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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, clinical laboratory evaluations, and 12-lead ECG, in the opinion of the investigator.
- •Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.
- •Able to provide written informed consent before any study-specific procedures are conducted.
- •Willing and able to comply with all study requirements, including fasting, dosing restrictions, and safety/tolerability assessments.
- •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, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the investigator's opinion, could interfere with participation or data interpretation.
- •Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m², or any clinically significant abnormal clinical laboratory findings.
- •Prior history of lactic acidosis.
- •Current or recent (within 14 days before first dose) use of prescription drugs, over-the-counter medications, herbal products, or dietary supplements, 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 at check-in.
- •Participation in another clinical trial or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before 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 or finding that, in the opinion of the investigator, would make the subject unsuitable for the study.
研究组 & 干预措施
Single-Arm Crossover
干预措施: Standard Metformin Immediate-Release Tablet (Drug)
Single-Arm Crossover
干预措施: Liquid Metformin 100 mg/mL (Drug)
Single-Arm Crossover
干预措施: Liquid Metformin 250 mg/mL (Drug)
结局指标
主要结局
Incidence of Gastrointestinal Treatment-Emergent Adverse Events (GI TEAEs)
时间窗: From each study dose through 24 hours postdose in each treatment period
Severity of Gastrointestinal Treatment-Emergent Adverse Events
时间窗: From each study dose through 24 hours postdose in each treatment period
次要结局
未报告次要终点