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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-12-01

Brief Summary

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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RDG-17012® capsule

RDG-17012 ® capsule(dabigatran etexilate tosylate)

Group Type EXPERIMENTAL

RDG-17012 Capsule

Intervention Type DRUG

Dabigatran Etexilate tosylate 150mg

Pradaxa® capsule

Pradaxa® capsule(dabigatran etexilate mesylate)

Group Type ACTIVE_COMPARATOR

Dabigatran Etexilate Mesylate 150 MG Oral Capsule

Intervention Type DRUG

Dabigatran Etexilate mesylate 150mg

Interventions

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RDG-17012 Capsule

Dabigatran Etexilate tosylate 150mg

Intervention Type DRUG

Dabigatran Etexilate Mesylate 150 MG Oral Capsule

Dabigatran Etexilate mesylate 150mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes