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The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD |
|
| Sequence 2 | Experimental | Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD |
|
| Sequence 3 | Experimental | Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD |
|
| Sequence 4 | Experimental | Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD |
|
| Sequence 5 | Experimental | Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-2011 10/20 mg | Drug | AD-2011 10/20 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration | Cmax of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours |
| Area under the plasma concentration versus time curve | AUCtau of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach Cmax | Tmax of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours |
| Concentration | Ctrough of the total ingredient of AD-2011 and AD-2012 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Jin Jang, M.D., Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33647189 | Derived | Huh KY, Lee SW, Lee SB, Kim KT, Jang IJ, Lee S. Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1290-1296. doi: 10.1002/cpdd.926. Epub 2021 Mar 1. |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Sequence 6 | Experimental | Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD |
|
| AD-2012 80mg | Drug | AD-2012 80mg tablet |
|
| AD-2011 10/20 mg + AD-2012 80mg | Drug | AD-2011 10/20 mg + AD-2012 80mg tablet |
|
| pre-dose to 24 hours |
| Elimination half-life | t1/2 of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours |
| Clearance | CL/F of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours |
| Volume of distribution | Vd/F of the total ingredient of AD-2011 and AD-2012 | pre-dose to 24 hours |
| Number of participants with adverse events | Incidence rate of adverse events | From Day 1 up to Day 45 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |