None listed
Conditions
Interventions
Drug : Sequence 1
1. Subjects received Lobeglitazone 0.5 mg daily for 12 days.
And subjects received Warfarin 25 mg once at D5.
2. 10 day-washout
3. Subjects received Warfarin 25 mg once at D1.
Se
Sponsors
Chong Kun Dang
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) A healthy male volunteer between 19 and 55 years old. 2) BMI between 19 and 27. 3) Signed the informed consent form prior to study participation. 4) Able to participate in the entire trial
Exclusion criteria
Exclusion criteria: 1) Clinically significant hepatic, renal, digestive system, respiratory system, endocrine system, nervous system, hematologic, cardiovascular system, tumor or have history of tumor 2) Clinically significant hemorrhagic disease 3) Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption 4) Have hypersensitivity reactions history for lobeglitazone, warfarin, excipient of IP or aspirin, antibiotics 5) Medication which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products within 30 days prior to screening 6) Participated in the other clinical trials and administrated IP within 60 days prior to screening 7) Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before screening 8) Previously donate whole blood within 60 days or component blood within 30 days 9) sit SBP 140 g/week) or cannot stop drinking 11) A heavy smoker (cigarette > 10 cigarettes per day) or cannot stop smoking 12) A heavy caffeine consumer (more than 4cups per a day) or A heavy grapefruit consumer (more than 1cup per a day) or cannot stop having 13)Positive for the Triage TOX drug on urine 14) Positive for HIV antibody, HBsAg, HCV antibody test 15) AST, ALT or Total bilirubin > UNL * 1.5 16) Estimated GFR < normal limit 17) INR, aPTT over the normal limit 18) Clinically significant laboratory test result 19) Clinically significant ECG 20) An impossible one who participates in clinical trial by investigator's decision including other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess Cmax, AUC of lobeglitazone;Assess Cmax, AUC of S-warfarin, R-warfarin | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess tmax, t1/2, CL/F, Vd/F of lobeglitazone;Assess tmax, t1/2, CL/F, Vd/F of S-warfarin, R-warfarin | — |
Countries
Korea, Republic of
Contacts
Public ContactJIn Ah Jung
Samsung Medical Center
Outcome results
None listed