A randomized, open-label, single-dose, crossover study
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
38
* Combination drug (Bazedoxifene + Cholecalciferol) * Incrementally modified drug * Not market authorized product
Co- Administration of Bazedoxifene and Cholecalciferol
Inha University Hospital
Junggu, Incheon, South Korea
Bio-Equivalence between test drug and comparators
To evaluate the bio-equivalence between co-administration of Bazedoxifene and Cholecalciferol and administration of HDDO-1614
Time frame: Day 1 ~ Day 27
Bazedoxifene Pharmacokinetic Assessment
Bazedoxifene Maximum Plasma Concentration
Time frame: 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
Time frame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
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