NCT03867942

BE Study of Bilayer Combination of Gemigliptin/Rosuvastatin 50/20mg in Comparison to Monolayer Combination.

Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of the Monolayer Drug in Comparison to the Bilayer Drug Administered in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate and compare PK/PD, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg and bilayer combination of Gemigliprin/Rosuvastatin 50/20mg in healthy adults.

Detailed description

To evaluate and compare Pharmacokinetics/Pharmacodynamics, safety and tolerability of monolayer combination of Gemigliptin/Rosuvastatin 50/20mg in comparison to bilayer combination of Gemigliprin/Rosuvastatin 50/20mg administered in healthy volunteers

Conditions

• Diabetes Mellitus, Type 2
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Monolayer group	Monolayered combination of gemigliptin and rosuvastatin
DRUG	Bilayer group	Bilayered combination of gemigliptin and rosuvastatin

Timeline

• Start date: 2019-03-21
• Primary completion: 2019-05-24
• Completion: 2019-08-31
• First posted: 2019-03-08
• Last updated: 2019-03-08