Drug-drug Interaction Study(Lobeglitazone, Warfarin)
- Registration Number
- NCT02002611
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and warfarin in healthy subjects.
- Detailed Description
From day 1 to day 12, lobeglitazone 0.5mg is administered daily to Group 1 subjects during period 1. Then on day 5,warfarin 25mg is co-administered Group 1 subjects at period 1. After 10 day-break, warfarin 25mg is administered Group 1 subjects at period 2. On period 2, lobeglitazone is not administered.
Group 2 is administered in reverse order.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- A healthy male volunteer between 19 and 55 years old.
- BMI between 19 and 27.
- Signed the informed consent form prior to study participation.
- Able to participate in the entire trial
Exclusion Criteria
- Clinically significant hepatic, renal, digestive system, respiratory system, endocrine system, nervous system, hematologic, cardiovascular system, tumor or have history of tumor
- Clinically significant hemorrhagic disease
- Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Have hypersensitivity reactions history for lobeglitazone, warfarin, excipient of IP or aspirin, antibiotics
- Medication which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products within 30 days prior to screening
- Participated in the other clinical trials and administrated IP within 60 days prior to screening
- Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before screening
- Previously donate whole blood within 60 days or component blood within 30 days
- sit SBP < 90mmHg or sit SBP ≥ 140mmHg or sit DBP < 60mmHg or sit DBP ≥ 90mmHg
- A heavy alcohol consumer (alcohol > 140 g/week) or cannot stop drinking
- A heavy smoker (cigarette > 10 cigarettes per day) or cannot stop smoking
- 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
- Positive for the Triage TOX drug on urine
- Positive for HIV antibody, HBsAg, HCV antibody test
- AST, ALT or Total bilirubin > UNL * 1.5
- Estimated GFR < normal limit
- INR, aPTT over the normal limit
- Clinically significant laboratory test result
- Clinically significant ECG
- An impossible one who participates in clinical trial by investigator's decision including other reason
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lobeglitazone Lobeglitazone Subjects received Lobeglitazone 0.5 mg daily for 12 days in one period and in the other period, Subjects don't receive Lobeglitazone. Warfarin Warfarin Subjects received Warfarin 25 mg once at period 1 and 2.
- Primary Outcome Measures
Name Time Method Assess Cmax of R-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess AUC of lobeglitazone 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h Assess Cmax of lobeglitazone 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h Assess Cmax of S-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess AUC of S-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess AUC of R-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
- Secondary Outcome Measures
Name Time Method Assess t1/2 of lobeglitazone 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h Assess tmax of S-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess t1/2 of R-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess Vd/F of R-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess tmax of lobeglitazone 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h Assess CL/F of lobeglitazone 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h Assess Vd/F of lobeglitazone 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h Assess CL/F of S-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess Vd/F of S-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess t1/2 of S-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess CL/F of R-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h Assess tmax of R-warfarin 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of