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

NCT ID: NCT07044765

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2025-11-30

Brief Summary

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

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Two-period, single-dose, crossover study

Group Type: EXPERIMENTAL

Comparator 1

Intervention Type: DRUG

Dapagliflozin 10mg + Linagliptin 5mg

Comparator 2

Intervention Type: DRUG

Metformin 1000mg

Test Drug

Intervention Type: DRUG

Fixed-dose combination tablet (AJU-A53)

Group B

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

Group Type: EXPERIMENTAL

Comparator 1

Intervention Type: DRUG

Dapagliflozin 10mg + Linagliptin 5mg

Comparator 2

Intervention Type: DRUG

Metformin 1000mg

Test Drug

Intervention Type: DRUG

Fixed-dose combination tablet (AJU-A53)

Interventions

Comparator 1

Dapagliflozin 10mg + Linagliptin 5mg

Intervention Type: DRUG

Comparator 2

Metformin 1000mg

Intervention Type: DRUG

Test Drug

Fixed-dose combination tablet (AJU-A53)

Intervention Type: DRUG

Eligibility Criteria

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 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.

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AJU Pharm Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

24-IP013

Identifier Type: -

Identifier Source: org_study_id