Osteoporosis
Conditions
Brief summary
A randomized, open-label, single-dose, crossover study
Detailed description
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).
Interventions
COMBINATION_PRODUCTHDDO-1614
* Combination drug (Bazedoxifene + Cholecalciferol) * Incrementally modified drug * Not market authorized product
DRUGBazedoxifene / Cholecalciferol
Co- Administration of Bazedoxifene and Cholecalciferol
Sponsors
Hyundai Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
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 1. AST or ALT \> 2 times upper limit of normal range 2. Total Bilirubin \> 2.0mg/dL 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bio-Equivalence between test drug and comparators | Day 1 ~ Day 27 | To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bazedoxifene Pharmacokinetic Assessment | 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours | Bazedoxifene Maximum Plasma Concentration |
| Cholecalciferol Pharmacokinetic Assessment | Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour | Maximum Plasma Concentration after correction of basal concentration of Cholecalciferol |
Countries
South Korea
Outcome results
None listed