Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

Sponsor
LG Chem
Study ID
NCT03565458
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
MALE
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Gemigliptin — DRUG
    zemiglo 50mg,LG Chem
  • Dapagliflozin — DRUG
    forxiga, dapagliflozin 10mg
  • Empagliflozin — DRUG
    jardiance 25mg, empagliflozin

Study Details

gemigliptin,SGLT-2i DDI study

Key Dates

Start date
Apr 5, 2018
Status verified
May 2018
Primary completion
Aug 20, 2018
Completion
Dec 22, 2018

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: gemigliptin
    gemigliptin single dose
  • Experimental: dapagliflozin
    dapagliflozin single dose
  • Experimental: gemigliptin and dapagliflozin
    co-administration of gemigliptin and dapagliflozin
  • Experimental: empagliflozin
    empagliflozin single dose
  • Experimental: gemigliptin and empagliflozin
    co-administration of gemigliptin and empagliflozin

Primary Outcome Measure

Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin [ Time Frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours ]

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