Drug-drug Interaction Study(Lobeglitazone, Warfarin)
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ClinicalTrials.gov Identifier: NCT02002611 |
Recruitment Status :
Completed
First Posted : December 6, 2013
Last Update Posted : July 3, 2014
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Condition or disease | Intervention/treatment | Phase |
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Type 2 Diabetes Mellitus | Drug: Lobeglitazone Drug: Warfarin | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
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 : | December 2013 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
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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.
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Drug: Lobeglitazone |
Experimental: Warfarin
Subjects received Warfarin 25 mg once at period 1 and 2.
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Drug: Warfarin |
- Assess AUC of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
- Assess Cmax of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
- Assess AUC of S-warfarin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
- Assess t1/2 of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
- Assess CL/F of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
- Assess Vd/F of lobeglitazone [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24h ]
- Assess tmax of S-warfarin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 0, 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168h ]

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Ages Eligible for Study: | 19 Years to 55 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002611
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of |
Principal Investigator: | Jae Wook Ko, Ph.D | Samsung Medical Center |
Responsible Party: | Chong Kun Dang Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT02002611 History of Changes |
Other Study ID Numbers: |
19DDI13016 |
First Posted: | December 6, 2013 Key Record Dates |
Last Update Posted: | July 3, 2014 |
Last Verified: | July 2014 |
Lobeglitazone Warfarin Type 2 Diabetes Mellitus Drug-Drug interaction Phase 1 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Warfarin Anticoagulants |