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

NCT05105698 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-11-03

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers

Interventions

DRUG

gemigliptin and dapagliflozin 50/10 mg film-coated tablet (Fasting)

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)

DRUG

gemigliptin and dapagliflozin 50/10 mg film-coated tablet (fed)

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)

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-02-28
Completion
2022-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05105698 on ClinicalTrials.gov