NCT04686825

The Food Effect on Pharmacokinetics of DA-8010 After a Single Administration of DA-8010 2.5 mg or 5 mg in Healthy Subjects

A Randomized, Open-label, Single-dose, 4-way Crossover Phase 1 Study to Evaluate the Food Effect on Pharmacokinetics of DA-8010 After a Single Administration of DA-8010 2.5 mg or 5 mg in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, single-dose, 4-way crossover phase 1 study to evaluate the food effect on pharmacokinetics of DA-8010 after a single administration of DA-8010 2.5 mg or 5 mg under fasting and fed states in healthy male and female subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DA-8010 2.5mg (Fasting)	Test drug l : DA-8010 2.5mg (Fasting)
DRUG	DA-8010 2.5mg (Fed)	Test drug ll : DA-8010 2.5mg (Fed)
DRUG	DA-8010 5mg (Fasting)	Test drug llI : DA-8010 5mg (Fasting)
DRUG	DA-8010 5mg (Fed)	Test drug lV : DA-8010 5mg (Fed)

Timeline

• Start date: 2021-01-13
• Primary completion: 2021-02-17
• Completion: 2021-03-11
• First posted: 2020-12-29
• Last updated: 2021-05-26

Locations

1 site across 1 country: South Korea