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The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.
This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Linagliptin and co-administration of Fimasartan and Linagliptin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period. |
|
| Sequence B | Experimental | Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period. |
|
| Sequency C | Experimental | Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A (Fimasartan, Linagliptin) | Drug | Co-administration of Fimasartan and Linagliptin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration of drug in plasma of Fimasartan, Linagliptin | Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration |
| AUClast | Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin | Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Dahak-ro | 03080 | South Korea |
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| Treatment B (Fimasartan/Linagliptin) | Drug | Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg |
|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |
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