NCT01232023

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

November 10, 2010

Status Verified

October 1, 2010

Enrollment Period

11 months

First QC Date

November 1, 2010

Last Update Submit

November 9, 2010

Conditions

Healthy

Keywords

Indobufenhealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    AUC, Cmax

    24 Hours

Secondary Outcomes (1)

  • Pharmacodynamics

    24 Hours

Study Arms (4)

100mg

EXPERIMENTAL

Wild type UGT1A : 3 / Variant type UGT1A : 3

Drug: Indobufen

200mg

EXPERIMENTAL

Wild type UGT1A : 3 / Variant type UGT1A : 3

Drug: Indobufen

400mg

EXPERIMENTAL

Wild type UGT1A : 3 / Variant type UGT1A : 3

Drug: Indobufen

800mg

EXPERIMENTAL

Wild type UGT1A : 3 / Variant type UGT1A : 3

Drug: Indobufen

Interventions

IndobufenDRUG

Single Oral Dose of

100mg200mg400mg800mg

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pusan National University Yangsan Hospital

Pusan, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Related Links

MeSH Terms

Interventions

indobufen

Study Officials

  • Hyeong-Seok Lim, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Last Updated

November 10, 2010

Record last verified: 2010-10

Locations

KR(2)