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

NCT03867942 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-03-08

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Dyslipidemias

Interventions

DRUG

Monolayer group

Monolayered combination of gemigliptin and rosuvastatin

DRUG

Bilayer group

Bilayered combination of gemigliptin and rosuvastatin

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Principal Investigators

  • kyungsang Yoo · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2019-05-24
Completion
2019-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867942 on ClinicalTrials.gov