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Trial record 74 of 7513 for:    Area Under Curve

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495739
Recruitment Status : Active, not recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Huons Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: RDG-17012 Capsule Drug: Dabigatran Etexilate Mesylate 150 MG Oral Capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 1, 2018

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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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495739


Locations
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Korea, Republic of
Huons
Gyeonggi-do, Seongnam-si, Korea, Republic of, 13486
Sponsors and Collaborators
Huons Co., Ltd.

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Responsible Party: Huons Co., Ltd.
ClinicalTrials.gov Identifier: NCT03495739     History of Changes
Other Study ID Numbers: HUG171
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants