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Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01232023
First received: November 1, 2010
Last updated: November 9, 2010
Last verified: October 2010
History of Changes
  Purpose

This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.


Condition Intervention Phase
Healthy
 Drug: Indobufen
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    AUC, Cmax


Secondary Outcome Measures:
  • Pharmacodynamics [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    Platelet Aggregation Test


Estimated Enrollment: 12
Study Start Date: January 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100mg
Wild type UGT1A : 3 / Variant type UGT1A : 3
 Drug: Indobufen
Single Oral Dose of
Experimental: 200mg
Wild type UGT1A : 3 / Variant type UGT1A : 3
 Drug: Indobufen
Single Oral Dose of
Experimental: 400mg
Wild type UGT1A : 3 / Variant type UGT1A : 3
 Drug: Indobufen
Single Oral Dose of
Experimental: 800mg
Wild type UGT1A : 3 / Variant type UGT1A : 3
 Drug: Indobufen
Single Oral Dose of

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult males aged 19 to 50 years at screening.
  • Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
  • Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

  • Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
  • Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232023

Locations
Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Pusan, Korea, Republic of
Contact: Sangmin Choe, M.D., Ph.D.     82-55-360-1732        
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hyeong-Seok Lim, M.D., Ph.D.     82-2-3010-4613        
Principal Investigator: Hyeong-Seok Lim, M.D., Ph.D.            
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Hyeong-Seok Lim, M.D., Ph.D. Asan Medical Center
  More Information

Additional Information:
Clinical Research Center, Asan Medical Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Asan Medical Center, Clinical Pharmacology & Therapeutics, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01232023     History of Changes
Other Study ID Numbers: 2009-0103
Study First Received: November 1, 2010
Last Updated: November 9, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Indobufen
healthy volunteers

Additional relevant MeSH terms:
Anticoagulants
Indobufen
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013