PK and Relative Bioavailability of Liquid Metformin vs Tablets in Healthy Adults

Официальное название

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

Обзор

The study will evaluate the pharmacokinetics and relative bioavailability of two liquid metformin formulations (100 mg/mL and 250 mg/mL)

Подробное описание

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.

Вмешательства

• Препарат Liquid Metformin 100 mg/mL
  A single oral dose of liquid metformin at a concentration of 100 mg/mL will be administered under fasting conditions in one treatment period of the crossover.
• Препарат Liquid Metformin 250 mg/mL
  A single oral dose of liquid metformin at a concentration of 250 mg/mL will be administered under fasting conditions in one treatment period of the crossover.

Первичные конечные точки

• Maximum Observed Plasma Concentration (Cmax) [Срок оценки: 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) [Срок оценки: Up to approximately 24 to 36 hours postdose in each treatment period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07300007 · ASP-016-MET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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