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The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers
This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raloxifene 60mg to AD-101 45mg | Experimental | Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral |
|
| AD-101 45mg to Raloxifene 60mg | Experimental | Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-101 45mg | Drug | Raloxifene 45mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Cmax of the total ingredient of AD-101 | pre-dose to 96 hours |
| Area under the curve in time plot (AUCt) | AUCt of the total ingredient of AD-101 | pre-dose to 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve in time plot (AUCinf) | AUCinf of the total ingredient of AD-101 | pre-dose to 96 hours |
| Time to reach Cmax | Tmax of the total ingredient of AD-101 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Incidence rate of adverse events | From Day 1 until 40 Days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Ran Yoon, M.D., Ph.D | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C523280 | AD 101 |
| D020849 | Raloxifene Hydrochloride |
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Raloxifene 60mg | Drug | Raloxifene 60mg tablet |
|
| pre-dose to 96 hours |
| Effective half-life | t1/2 of the total ingredient of AD-101 | pre-dose to 96 hours |
| Clearance | CL/F of the total ingredient of AD-101 | pre-dose to 96 hours |
| Volume of distribution | Vd/F of the total ingredient of AD-101 | pre-dose to 96 hours |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |