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

Sponsor
LG Chem
Study ID
NCT04544319
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

To identify bioequivalence between Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg to Each Component of Gemigliptin 50 mg and Dapagliflozin 10 mg

Key Dates

Start date
Oct 31, 2020
Status verified
Sep 2020
Primary completion
Mar 31, 2021
Completion
Jul 31, 2021

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Arm I
    Firstly, administrating each component Gemigliptin 50mg and dapagliflozin 10mg and after resting period administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg
  • Experimental: Arm II
    Firstly, administrating Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg and after resting period administrating each component Gemigliptin 50mg and dapagliflozin 10mg

Primary Outcome Measure

Gemigliptin and dapagliflozin AUClast and Cmax [ Time Frame: Pre-dose (Day1 0 hour) ]

Central Contacts

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