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Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-221 in healthy male subjects.
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-221 compared with coadministration AD-221A and AD-221B in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1 : Reference Drug(AD-221A and AD-221B) Period 2 : Test Drug(AD-221) |
|
| Sequence B | Experimental | Period 1 : Test Drug(AD-221) Period 2 : Reference Drug(AD-221A and AD-221B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-221 | Drug | AD-221 Oral Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Cmax of AD-221 | pre-dose to 72 hours |
| Area Under the Curve in time plot (AUCt) | AUCt of AD-221 | pre-dose to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H+ Yangji Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40206873 | Derived | Song J, Bae S, Yu KS, Lee S. Comparison of pharmacokinetics of a fixed-dose combination of atorvastatin/ezetimibe 5 mg/10 mg versus separate tablets in healthy subjects. Transl Clin Pharmacol. 2025 Mar;33(1):40-49. doi: 10.12793/tcp.2025.33.e5. Epub 2025 Mar 24. |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| AD-221A and AD-221B |
| Drug |
AD-221A Oral Tablet + AD-221B Oral Tablet |
|