Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects

Detailed Description
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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

Official Title
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A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Raloxifene 60mg/Cholecalciferol 800IU
* Drug: AD-102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit The Age between 19 and 50 in healthy male volunteers at the time of screening visit Exclusion Criteria: As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range As a result of laboratory tests, the following figures: 25-OH vitamin D total <9 ng/mL

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raloxifene 60mg/Cholecalciferol 800IU to AD-102<br>Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral | Drug: Raloxifene 60mg/Cholecalciferol 800IU<br>* Raloxifene 60mg/Cholecalciferol 800IU tablet<br>Drug: AD-102<br>* AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet<br>|
| Experimental: AD-102 to Raloxifene 60mg/Cholecalciferol 800IU<br>Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral | Drug: Raloxifene 60mg/Cholecalciferol 800IU<br>* Raloxifene 60mg/Cholecalciferol 800IU tablet<br>Drug: AD-102<br>* AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |