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

NCT07034781 | Not Yet Recruiting Phase 1

• 1 other identifier: 24-IP012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• Cmax of Dapagliflozin

  To assess the maximum observed plasma concentration (Cmax) of Dapagliflozin

  0 hour ~ 48 hour after drug administration

• AUCt of Dapagliflozin

  To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Dapagliflozin

  0 hour ~ 48 hour after drug administration

• Cmax of Linagliptin

  To assess the maximum observed plasma concentration (Cmax) of Linagliptin

  0 hour ~ 72 hour after drug administration

• AUCt of Linagliptin

  To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Linagliptin

  0 hour ~ 72 hour after drug administration

• Cmax of Metformin

  To assess the maximum observed plasma concentration (Cmax) of Metformin

  0 hour ~ 48 hour after drug administration

• AUCt of Metformin

  To assess the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCt) of Metformin

  0 hour ~ 48 hour after drug administration

Study Arms (2)

Group A

EXPERIMENTAL

Two-period, single-dose, crossover study

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

Group B

EXPERIMENTAL

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

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

Interventions

Comparator 1 DRUG

Dapagliflozin 10mg + Linagliptin 5mg

Group A; Group B

Comparator 2 DRUG

Metformin 1000mg

Group A; Group B

Test Drug DRUG

Fixed-dose combination tablet (AJU-A53)

Group A; Group B

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead

Study Sites (1)

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 24, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

KR (1)