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A study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
An open-label, randomized, multiple-dose crossover study to investigate drug interaction between D326, D337, and D013 in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Sequence1 | Experimental |
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| Part A, Sequence 2 | Experimental |
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| Part B, Sequence 1 | Experimental |
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| Part B, Sequence 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D013, D326 and D337 | Drug | Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days |
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| Measure | Description | Time Frame |
|---|---|---|
| AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) |
| 0(predose)~24 hours at Day7 and Day28 |
| Cmax,ss(Maximum plasma concentration of the drug at steady state) |
| 0(predose)~24 hours at Day7 and Day28 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmin,ss(Minimum concentration of the drug in plasma at steady state) |
| 0(predose)~24 hours at Day7 and Day28 |
| Tmax,ss(Time to maximum plasma concentration at steady state) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji-Young Park, M.D., Ph.D | Department of Pharmacology, College of Medicine/ Department of Clinical Pharmacology&Toxicology, Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
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| D013 | Drug | Daily oral administration of 1 tablet under fasting conditions for 7 days |
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| D326 and D337 | Drug | Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days |
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| 0(predose)~24 hours at Day7 and Day28 |
| t1/2(Terminal elimination half-life) |
| 0(predose)~24 hours at Day7 and Day28 |
| CLss/F(Apparent total body clearance of the drug from plasma at steady state) |
| 0(predose)~24 hours at Day7 and Day28 |
| Vd,ss/F(Apparent volume of distribution at steady state) |
| 0(predose)~24 hours at Day7 and Day28 |
| PTF(Peak-to-trough fluctuation) |
| 0(predose)~24 hours at Day7 and Day28 |
| D002318 | Cardiovascular Diseases |