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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03495739
• Other study ID #: HUG171
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 19, 2018
• Last updated: April 10, 2018
• Start date: February 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2018
• Source: Huons Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• RDG-17012 Capsule
Dabigatran Etexilate tosylate 150mg
• Dabigatran Etexilate Mesylate 150 MG Oral Capsule
Dabigatran Etexilate mesylate 150mg

Locations

Country	Name	City	State
Korea, Republic of	Huons	Gyeonggi-do	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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