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

Phase 1

• Conditions: Healthy
• Interventions: Drug: RDG-17012 Capsule; Drug: Dabigatran Etexilate Mesylate 150 MG Oral Capsule

• Registration Number: NCT03495739
• Lead Sponsor: Huons Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-03-19
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-10
• Last Update Submitted: 2018-04-10
• Study First Posted: 2018-04-12
• Last Update Posted: 2018-04-12
• Primary Completion: 2018-06-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

• Age between 19 to 45, healthy male subjects(at screening)
• Subject without a hereditary problems, chronic disease and morbid symptom
• Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

Exclusion Criteria

• Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
• Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
• History of drug abuse, or a positive urine drug screen
• Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
• Any condition that, in the view of the investigator, would interfere with study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RDG-17012® capsule	RDG-17012 Capsule	RDG-17012 ® capsule(dabigatran etexilate tosylate)
Pradaxa® capsule	Dabigatran Etexilate Mesylate 150 MG Oral Capsule	Pradaxa® capsule(dabigatran etexilate mesylate)

Primary Outcome Measures

Name	Time	Method
Maximum of concentration(Cmax) of Total dabigatran and Free dabigatran	(Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
Area Under Curve(AUC) last of Total dabigatran and Free dabigatran	(Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2

Secondary Outcome Measures

Name	Time	Method
Area Under Curve(AUC)inf of Total dabigatran and Free dabigatran	(Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2

Trial Locations

Locations (1)

Huons; 🇰🇷 Gyeonggi-do, Seongnam-si, Korea, Republic of