NCT04544319

Clinical Trial to Compare the PK of the Fixed-dose Combinations and Each Component of Gemigliptin/Dapagliflozin 50/10 mg

Clinical Trial to Compare the Pharmacokinetics, Safety and Tolerability of the FDC of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg Also we identify safety and tolerance of FDC and each component

Conditions

• T2DM

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-03-01
• Completion: 2021-07-01
• First posted: 2020-09-10
• Last updated: 2020-09-11