Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent
- Registration Number
- NCT01232023
- Lead Sponsor
- Asan Medical Center
- Brief Summary
This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 12
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 200mg Indobufen Wild type UGT1A : 3 / Variant type UGT1A : 3 100mg Indobufen Wild type UGT1A : 3 / Variant type UGT1A : 3 400mg Indobufen Wild type UGT1A : 3 / Variant type UGT1A : 3 800mg Indobufen Wild type UGT1A : 3 / Variant type UGT1A : 3
- Primary Outcome Measures
Name Time Method Pharmacokinetics 24 Hours AUC, Cmax
- Secondary Outcome Measures
Name Time Method Pharmacodynamics 24 Hours Platelet Aggregation Test
Trial Locations
- Locations (2)
Pusan National University Yangsan Hospital
🇰🇷Pusan, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of