Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg
NCT04544319 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2020-09-11
Summary
To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg
Conditions
- T2DM
Interventions
- DRUG
-
Zemiglo 50mg and Forxiga 10mg
Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD
- DRUG
-
Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD
Sponsors & Collaborators
-
LG Chem
lead INDUSTRY
Principal Investigators
-
seunghwan Lee · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-31
- Primary Completion
- 2021-03-31
- Completion
- 2021-07-31
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