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

April 10, 2018 updated by: Huons Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seongnam-si
      • Gyeonggi-do, Seongnam-si, Korea, Republic of, 13486
        • Huons

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RDG-17012® capsule
RDG-17012 ® capsule(dabigatran etexilate tosylate)
Drug: RDG-17012 Capsule
Dabigatran Etexilate tosylate 150mg
Active Comparator: Pradaxa® capsule
Pradaxa® capsule(dabigatran etexilate mesylate)
Drug: Dabigatran Etexilate Mesylate 150 MG Oral Capsule
Dabigatran Etexilate mesylate 150mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under Curve(AUC) last of Total dabigatran and Free dabigatran
Time Frame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
(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
Time Frame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
(Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under Curve(AUC)inf of Total dabigatran and Free dabigatran
Time Frame: (Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2
(Day0)0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour, Day 1, Day2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huons Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUG171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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