Drug-drug Interaction Study(Lobeglitazone, Warfarin)

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Warfarin; Drug: Lobeglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02002611

19DDI13016

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Lobeglitazone

Experimental group

Description:

Subjects received Lobeglitazone 0.5 mg daily for 12 days in one period and in the other period, Subjects don't receive Lobeglitazone.

Treatment:

Drug: Lobeglitazone

Warfarin

Experimental group

Description:

Subjects received Warfarin 25 mg once at period 1 and 2.

Treatment:

Drug: Warfarin