NCT03495739

Clinical Trial to Assess the Safety and Pharmacokinetics of RDG-17012 Capsule and Pradaxa® Capsule in Healthy Male Volunteers

A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of RDG-17012(Dabigatran Etexilate Tosylate) With Pradaxa® Capsule(Dabigatran Etexilate Mesylate) in Healthy Male Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Huons Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RDG-17012 Capsule	Dabigatran Etexilate tosylate 150mg
DRUG	Dabigatran Etexilate Mesylate 150 MG Oral Capsule	Dabigatran Etexilate mesylate 150mg

Timeline

• Start date: 2018-02-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2018-04-12
• Last updated: 2018-04-12

Locations

1 site across 1 country: South Korea