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The purpose of this study is to evaluate a pharmacokinetic drug interaction between sitagliptin and lobeglitazone in healthy male volunteers.
To healthy male subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1(Treatment A/Treatment B) | Experimental | Period 1: Treatment A(Januvia Tab. 100mg)*1T/day for 5 days, QD, PO. Period 2: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)*1T/day for 5 dyas, QD, PO. Each treatment period was separated by a washout period of at least 10 dyas. |
|
| Group 2(Treatment B/Treatment A) | Experimental | Period 1: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)*1T/day for 5 dyas, QD, PO. Period 2: Treatment A(Januvia Tab. 100mg)*1T/day for 5 dyas, QD, PO. Each treatment period was separated by a washout period of at least 10 dyas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Januvia Tab. 100mg | Drug | Januvia Tab. 100mg*1T/day for 5days, QD, PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„ of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | |
| Css,max of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h |
| Measure | Description | Time Frame |
|---|---|---|
| Css,min of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h | |
| Css,av of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min-Gul Kim, MD,PhD | Chonbuk National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32362346 | Derived | Moon SJ, Yu KS, Kim MG. An Assessment of Pharmacokinetic Interaction Between Lobeglitazone and Sitagliptin After Multiple Oral Administrations in Healthy Men. Clin Ther. 2020 Jun;42(6):1047-1057. doi: 10.1016/j.clinthera.2020.04.005. Epub 2020 Apr 30. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| C546215 | lobeglitazone |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Januvia Tab. 100mg + Duvie Tab. 0.5mg | Drug | Januvia Tab.100mg + Duvie Tab. 0.5mg*1T/day for 5 dyas, QD, PO |
|
|
| Tss,max of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h |
| t1/2 of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h |
| CLss/F of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h |
| Vdss/F of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h |
| fluctuation[(Css,max-Css,min)/Css,av] of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h |
| swing[(Css,max-Css,min)/Css,min] of Sitagliptin | 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h |
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |