Bioequivalence of Liquid Metformin (100 mg/mL and 250 mg/mL) and Immediate-Release Metformin Tablets: A Randomized, Crossover Study in Adult Subjects
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 Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Metformin
研究概览
简要总结
This is an open-label, randomized, two-treatment, two-period crossover study evaluating the bioequivalence of liquid metformin formulations at 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy adult subjects. Each participant will receive both treatments in randomized sequence with an adequate washout interval between periods. Serial blood samples will be collected to assess metformin pharmacokinetics, and safety will be monitored 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, clinical laboratory tests, and 12-lead ECG, 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.
- •Able to understand and provide written informed consent prior to participation in the study.
- •Willing and able to comply with all study requirements, including fasting requirements and pharmacokinetic blood sampling.
- •Females of childbearing potential must use an acceptable method of 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 disorder 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 abnormal clinical laboratory findings.
- •History of lactic acidosis.
- •Use of prescription or over-the-counter medications, herbal supplements, or dietary supplements within 14 days before the first study dose, 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 trial 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 or more of blood, or significant blood loss, within 8 weeks before first study dose.
- •Pregnant or breastfeeding females.
- •Women of childbearing potential not using acceptable contraception.
- •Any condition or situation 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
干预措施: Liquid Metformin 100 mg/mL (Drug)
Single-Arm Crossover
干预措施: 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