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

Conditions

• Fasting
• Fed
• Healthy

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg — DRUG
  All participants will receive a single tablet of the study drug (a fixed-dose combination of gemigliptin/dapagliflozin/metformin 50/10/1000 mg) under either fasting or fed conditions.

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

First listed

Feb 9, 2026

Start date

Jun 11, 2026

Status verified

Sep 2026

Primary completion

Jun 26, 2026

Completion

Jun 26, 2026

Study Design

Enrollment

28 participants (actual)

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 ]

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