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A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1 : Reference Drug(Duodart capsule), Period 2 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg) Single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 1, followed by single-dose oral administration of AD-116 (Duodart capsule) in Period 2. |
|
| Sequence B | Experimental | Period 1 : Test Drug(dutasteride 0.5 mg / tamsulosin 0.4 mg), Period 2 : Reference Drug(Duodart capsule) ) Single-dose oral administration of AD-116 (Duodart capsule) in Period 1, followed by single-dose oral administration of AD-1161 (dutasteride 0.5 mg / tamsulosin 0.4 mg) in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-116, AD-1161 | Drug | Single-dose oral administration of AD-116 or AD-1161, according to randomized sequence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve during dosing interval (AUCt) | AUCt of AD-116 | pre-dose (0hour) to 72hours |
| Maximum concentration of drug in plasma (Cmax) | Cmax of AD-116 | pre-dose (0hour) to 72hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JaeHun Jung | Contact | +82-31-891-5683 | jhjung@addpharma.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H PLUS YANGJI HOSPITAL, Seoul | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| D052801 |
| Male Urogenital Diseases |