Type 2 Diabetes Mellitus
Conditions
Keywords
Lobeglitazone, Warfarin, Type 2 Diabetes Mellitus, Drug-Drug interaction, Phase 1
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.
Interventions
DRUGLobeglitazone
DRUGWarfarin
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 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 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 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 |
| 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 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 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 t1/2 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 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 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 |
Countries
South Korea
Outcome results
None listed