This Study is to Compare and Evaluate the Safety and Pharmacokinetic Characteristics (PK) After Administration of DW6014 and Each Component(Empagliflozin and Metformin) in Healthy Adult Volunteers in Fast Condition.
NCT05823870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2023-05-26
Summary
This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6014 and each component in healthy adult volunteers in fast condition.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
DW6014
Drug: DW6014 Single oral administration of DW6014 after an overnight fast Drug: Empagliflozin and Metformin Combination oral administration of Empagliflozin and Metformin after an overnight fast
Sponsors & Collaborators
-
Dong Wha Pharmaceutical Co. Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-02-24
- Primary Completion
- 2023-03-06
- Completion
- 2023-03-20
Countries
- South Korea
Study Locations
More Related Trials
-
Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers
NCT02102932 ·Status: COMPLETED ·Phase: PHASE1
-
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets
NCT02821910 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)
NCT04064073 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
NCT01540487 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Profiles of Metformin With DW1029M
NCT02212756 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults
NCT07034781 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
NCT01719003 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
NCT01560481 ·Status: COMPLETED ·Phase: PHASE1
-
Metformin Hydrochloride and Empagliflozin Tablets in the Treatment of Type 2 Diabetes
NCT07003191 ·Status: ACTIVE_NOT_RECRUITING
-
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
NCT05505994 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of the Safety and Efficacy of MK-3577 in Participants With Type 2 Diabetes Mellitus (MK-3577-009)
NCT00868790 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)
NCT02004886 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes
NCT05440591 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
NCT01055691 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Metformin on Insulin Sensitivity and Pan-Arterial Vascular Function in Adults With Metabolic Syndrome
NCT02633488 ·Status: COMPLETED ·Phase: NA
-
An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients
NCT02435277 ·Status: COMPLETED ·Phase: PHASE2
-
Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects
NCT00857870 ·Status: COMPLETED ·Phase: PHASE4
-
A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin
NCT00519480 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of BMS-770767 in Subjects With Type 2 Diabetes
NCT01046422 ·Status: COMPLETED ·Phase: PHASE2
-
Metformin in Gestational Diabetes Mellitus
NCT00681460 ·Status: COMPLETED ·Phase: NA
-
Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients
NCT02151461 ·Status: COMPLETED ·Phase: PHASE2
-
The Effect of Henagliflozin and Metformin on Myocardial Tissue-level Characteristics
NCT06059287 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin
NCT05376969 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients
NCT05226897 ·Status: UNKNOWN ·Phase: PHASE3