The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers

Sponsor
LG Chem
Study ID
NCT07396844
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Fasting
  • Fed
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a single dose, randomized, open-label, two-way crossover study to investigate the food-effect bioavailability of the fixed-dose combination of Gemigliptin/Dapagliflozin/Metformin 50/10/1000 mg in healthy volunteers under fasting and fed conditions.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Group 1 : Period 1 (Fasting) - Period 2 (Fed)
  • Experimental: Group 2
    Group 2 : Period 1 (Fed) - Period 2 (Fasting)

Primary Outcome Measure

The plasma concentration of Gemigliptin, Dapagliflozin and Metformin. [ Time Frame: 17 times up to 72 hours after IP administration ]

Central Contacts

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