Drug-drug Interaction Study(Lobeglitazone, Warfarin)

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and warfarin in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Warfarin

Criteria

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