Drug-drug Interaction Study(Lobeglitazone, Warfarin)

Not Applicable

Completed

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0000999
• Lead Sponsor: Chong Kun Dang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

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

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 < 90mmHg or sit SBP = 140mmHg or sit DBP < 60mmHg or sit DBP = 90mmHg
10) A heavy alcohol consumer (alcohol > 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess Cmax, AUC of lobeglitazone;Assess Cmax, AUC of S-warfarin, R-warfarin

Secondary Outcome Measures

Name	Time	Method
Assess tmax, t1/2, CL/F, Vd/F of lobeglitazone;Assess tmax, t1/2, CL/F, Vd/F of S-warfarin, R-warfarin