Drug-drug Interaction Study(Lobeglitazone, Warfarin)

NCT ID: NCT02002611

Last Updated: 2014-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-05-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lobeglitazone

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

Group Type: EXPERIMENTAL

Lobeglitazone

Intervention Type: DRUG

Warfarin

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

Group Type: EXPERIMENTAL

Warfarin

Intervention Type: DRUG

Interventions

Lobeglitazone

Intervention Type: DRUG

Warfarin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Wook Ko, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

19DDI13016

Identifier Type: -

Identifier Source: org_study_id