NCT04473417

Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects

An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2811 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and Forxiga® after a single oral dose in healthy volunteers. The study will also compare the pharmacokinetics and safety profiles of DA-2811 under fasting and fed states in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Forxiga	single dose administration after 10hr fasting
DRUG	DA-2811	single dose administration after 10hr fasting
DRUG	DA-2811	single dose administration after 10hr fasting
DRUG	DA-2811	single dose administration after high fat and calorie fed diet

Timeline

• Start date: 2020-08-04
• Primary completion: 2020-08-26
• Completion: 2020-10-12
• First posted: 2020-07-16
• Last updated: 2021-03-05

Locations

1 site across 1 country: South Korea