NCT05991401

Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults

An Open-label, Fixed-sequence, Phase 1 Clinical Trial to Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DA-8010 5mg	\[Period 1\] DA-8010 5mg \[Period 2\] DA-8010 5mg, Clarithromycin 500mg \[Period 3\] DA-8010 5mg, Rifampicin 600mg
DRUG	Clarithromycin 500mg	\[Period 2\] DA-8010 5mg, Clarithromycin 500mg
DRUG	Rifampicin 600mg	\[Period 3\] DA-8010 5mg, Rifampicin 600mg

Timeline

• Start date: 2023-08-18
• Primary completion: 2023-11-06
• Completion: 2023-11-17
• First posted: 2023-08-14
• Last updated: 2024-01-25

Locations

1 site across 1 country: South Korea