NCT04393597

Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics of Orally Administered DWJ1458 in Healthy Adults

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.

Detailed description

The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DWJ1458 (fasted)	Subjects take single dose of DWJ1458 on a fated condition
DRUG	DWJ1458 (fed)	Subjects take single dose of DWJ1458 after high-fat diet

Timeline

• Start date: 2020-05-28
• Primary completion: 2020-07-31
• Completion: 2020-11-30
• First posted: 2020-05-19
• Last updated: 2020-06-12

Locations

1 site across 1 country: South Korea