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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03495739

Enrollment

Registered

2018-04-12

Start date

2018-02-01

Completion date

2018-12-01

Last updated

2018-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGRDG-17012 Capsule

Dabigatran Etexilate tosylate 150mg

DRUGDabigatran Etexilate Mesylate 150 MG Oral Capsule

Dabigatran Etexilate mesylate 150mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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
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

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026