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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Huons Co., Ltd.; Huons Co.,Ltd.
• Treatments: Dabigatran

Criteria

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