NCT07044765

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: AJU Pharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Comparator 1	Dapagliflozin 10mg + Linagliptin 5mg
DRUG	Comparator 2	Metformin 1000mg
DRUG	Test Drug	Fixed-dose combination tablet (AJU-A53)

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: South Korea