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

Asan Medical Center

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Indobufen

Study type: Interventional

Funder types: Other

Identifiers

NCT01232023

2009-0103

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

100mg

Experimental group

Description:

Wild type UGT1A : 3 / Variant type UGT1A : 3

Treatment:

Drug: Indobufen

200mg

Experimental group

Description:

Wild type UGT1A : 3 / Variant type UGT1A : 3

Treatment:

Drug: Indobufen

400mg

Experimental group

Description:

Wild type UGT1A : 3 / Variant type UGT1A : 3

Treatment:

Drug: Indobufen

800mg

Experimental group

Description:

Wild type UGT1A : 3 / Variant type UGT1A : 3

Treatment:

Drug: Indobufen