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

Huons

Status and phase

Unknown

Phase 1

Conditions

Healthy

Treatments

Drug: RDG-17012 Capsule

Drug: Dabigatran Etexilate Mesylate 150 MG Oral Capsule

Study type

Interventional

Funder types

Industry

Identifiers

HUG171

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

Male

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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