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

• Sponsor: Asan Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01232023
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arms: 4
• Patients Per Site: 6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Indobufen	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics [24 Hours]

   AUC, Cmax

Secondary Outcome Measures

1. Pharmacodynamics [24 Hours]

   Platelet Aggregation Test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Yangsan Hospital	Pusan		Korea, Republic of
2	Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Asan Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Research Center, Asan Medical Center

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01232023
• Other Study ID Numbers: 2009-0103
• First Posted: Nov 2, 2010
• Last Update Posted: Nov 10, 2010
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: Indobufen; healthy volunteers
• Additional relevant MeSH terms: Indobufen

Study Results

No Results Posted as of Nov 10, 2010