Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects
This study is to evaluate the pharmacokinetic characteristics and safety of AD-102 compared with administration of raloxifen 60 mg + Cholecalciferol 800IU in healthy male subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raloxifene 60mg/Cholecalciferol 800IU to AD-102 | Experimental | Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral |
|
| AD-102 to Raloxifene 60mg/Cholecalciferol 800IU | Experimental | Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raloxifene 60mg/Cholecalciferol 800IU | Drug | Raloxifene 60mg/Cholecalciferol 800IU tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Cmax of Raloxifene | pre-dose to 96 hours |
| Peak Plasma Concentration (Cmax) | Cmax of corrected Cholecalciferol | pre-dose to 72 hours |
| Area under the curve in time plot (AUCt) | AUCt of Raloxifene | pre-dose to 96 hours |
| Area under the curve in time plot (AUCt) | AUCt of corrected Cholecalciferol | pre-dose to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve in time plot (AUCinf) | AUCinf of Raloxifene | pre-dose to 96 hours |
| Area under the curve in time plot (AUCinf) | AUCinf of Corrected Cholecalciferol |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Incidence rate of adverse events | From Day 1 until 32 Days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hosptial | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020849 | Raloxifene Hydrochloride |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AD-102 | Drug | AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet |
|
| pre-dose to 72 hours |
| Time to reach Cmax | Tmax of Raloxifene | pre-dose to 96 hours |
| Time to reach Cmax | Tmax of Corrected Cholecalciferol | pre-dose to 72 hours |
| Effective half-life | t1/2 of Raloxifene | pre-dose to 96 hours |
| Effective half-life | t1/2 of Corrected Cholecalciferol | pre-dose to 72 hours |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |