A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults: Fed State Study
NCT07044765 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2025-07-01
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
- DRUG
-
Comparator 1
Dapagliflozin 10mg + Linagliptin 5mg
- DRUG
-
Comparator 2
Metformin 1000mg
- DRUG
-
Test Drug
Fixed-dose combination tablet (AJU-A53)
Sponsors & Collaborators
-
AJU Pharm Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-31
- Primary Completion
- 2025-11-30
- Completion
- 2025-11-30
Countries
- South Korea
Study Locations
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