Single-Dose Pharmacokinetics and Relative Bioavailability of a Novel Liquid Metformin Formulation (100 mg/mL and 250 mg/mL) Compared With Immediate-Release Metformin Tablets in Adult Subjects
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Aspargo Labs, Inc
- 入组人数
- 24
- 主要终点
- Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Metformin
概览
简要总结
This is an open-label, randomized, three-period crossover study evaluating the single-dose pharmacokinetics and relative bioavailability of a novel liquid metformin formulation at concentrations of 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy adult subjects. All participants will receive each formulation in randomized sequence with washout periods between treatments. Serial blood samples will be collected to characterize metformin pharmacokinetic parameters, and safety and tolerability will be assessed throughout the study.
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 tests, in the opinion of the investigator.
- •Non-smoker or light smoker (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement periods, as determined by the investigator.
- •Able to understand and provide written informed consent before any study-specific procedures are performed.
- •Willing and able to comply with all study requirements, including fasting requirements, visit schedules, and pharmacokinetic blood sampling.
- •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 component of the study formulations.
- •History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the opinion of the investigator, could interfere with study participation or interpretation of results.
- •Estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m², or any clinically significant abnormality in clinical laboratory tests.
- •History of lactic acidosis.
- •Use of any prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before the first study dose, unless considered acceptable 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 admission to the clinical unit.
- •Participation in another clinical trial or receipt of an investigational drug or device within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before the first study dose.
- •Donation of 450 mL or more of blood, or significant blood loss, within 8 weeks before the first study dose.
- •Pregnant or breastfeeding females.
研究组 & 干预措施
Single-Arm Crossover
干预措施: Novel Liquid Metformin 100 mg/mL (Drug)
Single-Arm Crossover
干预措施: Novel Liquid Metformin 250 mg/mL (Drug)
Single-Arm Crossover
干预措施: Metformin Immediate-Release Tablet (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Metformin
时间窗: Up to approximately 24 to 36 hours postdose in each treatment period
Maximum Observed Plasma Concentration (Cmax) of Metformin
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