A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults: Fed State Study

Официальное название

An Open-label, 2-arm, Single-sequence, Fed, Single Oral Dosing, Crossover Clinical Trial to Evaluate Safety and the Pharmacokinetics Between Dapagliflozin, Linagliptin and Metformin in Healthy Adult Subjects

Обзор

To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults after taking the drugs with food (fed state).

Вмешательства

• Препарат Comparator 1
  Dapagliflozin 10mg + Linagliptin 5mg
• Препарат Comparator 2
  Metformin 1000mg
• Препарат Test Drug
  Fixed-dose combination tablet (AJU-A53)

Первичные конечные точки

• Cmax of Metformin [Срок оценки: 0 hour ~ 48 hour after drug administration]
• AUCt of Metformin [Срок оценки: 0 hour ~ 48 hour after drug administration]

Критерии участия

Критерии включения

• Healthy adult volunteers aged 19 to 50 years at the time of screening.
• Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.

• Male subjects must weigh ≥50 kg.
• Female subjects must weigh ≥45 kg.
• No clinically significant congenital or chronic diseases requiring treatment, based on medical history and physical examination.
• Clinically acceptable results from laboratory tests (e.g., hematology, biochemistry, serology, urinalysis) and electrocardiogram (ECG) at screening, as determined by the investigator.
• Willing to use medically accepted contraception (excluding hormonal methods) from the first dose until 7 days after the last dose, and agrees not to donate sperm or eggs during this period.
• Able and willing to provide written informed consent after receiving a full explanation of the study.

Критерии исключения

• Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.
• Participation in any clinical trial involving investigational products within 6 months prior to the first dose.
• Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.
• History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).
• History of excessive alcohol consumption within 1 month prior to the first dose:

• >21 drinks/week for males, >14 drinks/week for females (1 drink = 50 mL soju, 30 mL whiskey, or 250 mL beer)
• Known hypersensitivity to any component of the investigational product.
• Clinically significant renal, hepatic, cardiovascular, respiratory, metabolic, or infectious diseases, including but not limited to:

• Moderate to severe renal impairment (eGFR or creatinine clearance <45 mL/min)
• Dialysis
• Acute or unstable heart failure
• Acute myocardial infarction, septicemia, or shock
• Type 1 diabetes, metabolic acidosis, or history of diabetic ketoacidosis
• Major surgery planned during the study (except minor procedures not affecting food or fluid intake)
• Severe infections, trauma, or nutritional deficiencies
• Positive pregnancy test or currently breastfeeding (for female subjects).
• History of significant psychiatric illness.
• Determined by the investigator to be unsuitable for the study for any other reason.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong

Идентификаторы

NCT: NCT07044765 · 24-IP013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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