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
1 other identifier
interventional
64
1 country
1
Brief Summary
A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Feb 2018
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 19, 2018
CompletedFirst Posted
Study publicly available on registry
April 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 12, 2018
April 1, 2018
4 months
March 19, 2018
April 10, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
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
Study Arms (2)
RDG-17012® capsule
EXPERIMENTALRDG-17012 ® capsule(dabigatran etexilate tosylate)
Pradaxa® capsule
ACTIVE COMPARATORPradaxa® capsule(dabigatran etexilate mesylate)
Interventions
Dabigatran Etexilate mesylate 150mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huons Co., Ltd.lead
Study Sites (1)
Huons
Gyeonggi-do, Seongnam-si, 13486, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2018
First Posted
April 12, 2018
Study Start
February 1, 2018
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
April 12, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share