Evaluating the Pharmacokinetic Characteristics of AD-101 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-101 in healthy volunteers

Detailed Description
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This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults

Official Title
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A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: AD-101 45mg
* Drug: Raloxifene 60mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Adult aged 19 and more at the time of screening visit Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination Exclusion Criteria: Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration) History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs As a result of laboratory tests, the following figures: ALT or AST> 2 times upper limit of normal range

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

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 to AD-101 45mg<br>Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral | Drug: AD-101 45mg<br>* Raloxifene 45mg tablet<br>* Other names: AD-101;Drug: Raloxifene 60mg<br>* Raloxifene 60mg tablet<br>|
| Experimental: AD-101 45mg to Raloxifene 60mg<br>Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral | Drug: AD-101 45mg<br>* Raloxifene 45mg tablet<br>* Other names: AD-101;Drug: Raloxifene 60mg<br>* Raloxifene 60mg 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 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |