NCT03200496

Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects

Comparisons of Pharmacokinetics and Safety/Tolerability Profiles Between DA-5206 and Talion® Under Fasting and Fed States in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DA-5206(Fasting)	Test drug l : DA-5206(Fasting)
DRUG	DA-5206(Fed)	Test drug ll : DA-5206(Fed)
DRUG	TALION®	Reference drug : Talion®

Timeline

• Start date: 2017-05-29
• Primary completion: 2017-06-29
• Completion: 2017-06-29
• First posted: 2017-06-27
• Last updated: 2017-07-11

Locations

1 site across 1 country: South Korea