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A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects
A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, crossover study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental | Evogliptin Pioglitazone Evogliptin+Pioglitazone |
|
| B group | Experimental | Pioglitazone Evogliptin Evogliptin+Pioglitazone |
|
| C group | Experimental | Evogliptin Evogliptin+Pioglitazone Pioglitazone |
|
| D group | Experimental | Pioglitazone Evogliptin+Pioglitazone Evogliptin |
|
| E group | Experimental | Evogliptin+Pioglitazone Evogliptin Pioglitazone |
|
| F group | Experimental | Evogliptin+Pioglitazone Pioglitazone Evogliptin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evogliptin, Pioglitazone, Evogliptin+Pioglitazone | Drug | Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | area under the concentration-time curve | 1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, M.D., Ph.D. | Clinical Trials Center, Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Seoul National University Hospital | Seoul | 03080 | South Korea |
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|
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| Pioglitazone, Evogliptin, Evogliptin+Pioglitazone | Drug | Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD |
|
|
| Evogliptin, Evogliptin+Pioglitazone, Pioglitazone | Drug | Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD |
|
|
| Pioglitazone, Evogliptin+Pioglitazone, Evogliptin | Drug | Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD |
|
|
| Evogliptin+Pioglitazone, Evogliptin, Pioglitazone | Drug | Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD |
|
|
| Evogliptin+Pioglitazone, Pioglitazone, Evogliptin | Drug | Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD |
|
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C557982 | 4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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