Drug-drug Interaction Study(Lobeglitazone, Warfarin)

Sponsor

Chong Kun Dang Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT02002611

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Lobeglitazone Drug: Warfarin	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open Label, Randomized, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Lobeglitazone and Warfarin in Healthy Subjects

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lobeglitazone Subjects received Lobeglitazone 0.5 mg daily for 12 days in one period and in the other period, Subjects don't receive Lobeglitazone.	Drug: Lobeglitazone
Experimental: Warfarin Subjects received Warfarin 25 mg once at period 1 and 2.	Drug: Warfarin

Arm

Intervention/Treatment

Experimental: Lobeglitazone

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

Drug: Lobeglitazone

Experimental: Warfarin

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

Drug: Warfarin

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Assess tmax of lobeglitazone [0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h]
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]
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 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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts 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