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

November 9, 2010 updated by: Asan Medical Center
This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

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
      • Pusan, Korea, Republic of
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
          • Sangmin Choe, M.D., Ph.D.
          • Phone Number: 82-55-360-1732
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Hyeong-Seok Lim, M.D., Ph.D.
          • Phone Number: 82-2-3010-4613
        • Principal Investigator:
          • Hyeong-Seok Lim, M.D., Ph.D.

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 to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

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: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: 24 Hours
AUC, Cmax
24 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamics
Time Frame: 24 Hours
Platelet Aggregation Test
24 Hours

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Hyeong-Seok Lim, M.D., Ph.D., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (ESTIMATE)

November 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0103

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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