Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg

Conditions

• Healthy Volunteers

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting) — DRUG
  Subjects will check-in a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.(fasting)
• gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed) — DRUG
  Subjects will check-in a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.(fed)

Study Details

A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet under Fed and Fasting Conditions in Healthy Volunteers

Key Dates

Start date

Jan 1, 2022

Status verified

Oct 2021

Primary completion

Feb 28, 2022

Completion

Sep 30, 2022

Study Design

Enrollment

28 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: fasting conditions
  A: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once without food (fasting conditions)
• Experimental: fed conditions
  B: A fixed dose combination of gemigliptin and dapagliflozin 50/10 mg film-coated tablet orally administered once with food (fed conditions)

Primary Outcome Measure

Peak Plasma Concentration (Cmax) [ Time Frame: Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00 ]

Central Contacts

• eunjoo cho
  +82-2-6987-4284
  [email protected]

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