HDDO-1614 Bio Equivalence Study

Study Overview
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Brief Summary
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A randomized, open-label, single-dose, crossover study

Detailed Description
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This clinical trial is conducted with a randomized, open-label, single-dose, and cross over study designs. Investigators will compare the pharmacokinetic parameters of test drug(single oral dose, single administration) with pharmacokinetic parameters of comparator 1 and 2(combined administration, single oral dose).

Official Title
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A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics After Co-administration of HDDO-16141 and HDDO-16143 and Administration of HDDO-1614 in Healthy Adult Male Subjects

Conditions
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Osteoporosis

Intervention / Treatment
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* Combination Product: HDDO-1614
* Drug: Bazedoxifene / 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, and 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 ≤ 100mm Hg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg) Those who have a history of drug 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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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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HDDO-1614<br>Bazedoxifene + Cholecalciferol combination drug | Combination Product: HDDO-1614<br>* Combination drug (Bazedoxifene + Cholecalciferol) Incrementally modified drug Not market authorized product<br>|
| Active Comparator: Bazedoxifene + Cholecalciferol<br>Co-administration of Bazedoxifene and Cholecalciferol | Drug: Bazedoxifene / Cholecalciferol<br>* Co- Administration of Bazedoxifene and Cholecalciferol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bio-Equivalence between test drug and comparators | To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614 | Day 1   Day 27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bazedoxifene 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 | 
| Cholecalciferol Pharmacokinetic Assessment | Maximum 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 |