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

Aju Pharm

Status and phase: Begins enrollment this month; Phase 1

Conditions: Type2 Diabetes Mellitus

Treatments: Drug: Comparator 2; Drug: Test Drug; Drug: Comparator 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07034781

24-IP012

Details and patient eligibility

About

To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults

Enrollment: 50 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 50 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group A

Experimental group

Description:

Two-period, single-dose, crossover study

Treatment:

Drug: Test Drug

Drug: Comparator 1

Drug: Comparator 2

Group B

Experimental group

Description:

Two-period, single-dose, crossover study (reversed order)

Treatment:

Drug: Test Drug

Drug: Comparator 1

Drug: Comparator 2