HDDO-1614 Intervention Trial

Study Overview
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Brief Summary
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Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study

Official Title
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A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-16141 and HDDO-16142 in Healthy Adult Subjects

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Bazedoxifene 20 mg
* Drug: Cholecalciferol
* Drug: Bazedoxifene 20mg and Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight 50kg ≤ / BMI=18 29kg/㎡ A person who is determined to be eligible for the test through a physical examination or an interview Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test Exclusion Criteria: Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials Any person who shows any of the following results in the screening test AST or ALT > 2 times upper limit of normal range Total Bilirubin > 2.0mg/dL Glomerular filtration rate (eGFR) < 60mL / min/ 1.7㎡ Those who show signs of hypotension (systolic blood pressure ≤ 100mmHg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg) Those who have a history of drug abuse or who have a positive urine drug test

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bazedoxifene 20mg<br>Subjects will take bazedoxifene 1 Tablet. | Drug: Bazedoxifene 20 mg<br>* To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.<br>|
| Active Comparator: Cholecalciferol<br>Subjects will take Cholecalciferol 2 Tablets. | Drug: Cholecalciferol<br>* To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.<br>|
| Experimental: Bazedoxifene 20mg and Cholecalciferol<br>Subjects will take bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once. | Drug: Bazedoxifene 20mg and Cholecalciferol<br>* For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug-Drug Interaction | To compare the pharmacokinetic assessment between each comparative drug and combination of bazedoxifene and cholecalciferol. | Day 1 Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Assessment | Bazedoxifene Maximum Plasma Concentration | 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours | 
| Pharmacokinetic Assessment | Bazedoxifene Area Under Curve | 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours | 
| Pharmacokinetic Assessment | Maximun Plasma Concentration after correction of basal concentration of Cholecalciferol | Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour | 
| Pharmacokinetic Assessment | Area Under Curve after correction of basal concentration of Cholecalciferol | Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour |