Healthy
Conditions
Keywords
Indobufen, healthy volunteers
Brief summary
This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.
Interventions
DRUGIndobufen
Single Oral Dose of
Sponsors
Asan Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 24 Hours | AUC, Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics | 24 Hours | Platelet Aggregation Test |
Countries
South Korea
Outcome results
None listed