NCT05105698

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

Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet Under Fed and Fasting Conditions in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

\[Objectives\] * Primary: To investigate the food-effect bioavailability of absorption of gemigliptin and dapagliflozin 50/10 mg fixed dose combination film-coated tablet in healthy subjects under fed and fasting conditions * Secondary: To evaluate safety of investigational product under fed and fasting conditions

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-02-28
• Completion: 2022-09-30
• First posted: 2021-11-03
• Last updated: 2021-11-03