Osteoporosis
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects
Detailed description
This study is to evaluate the pharmacokinetic characteristics and safety of AD-102 compared with administration of raloxifen 60 mg + Cholecalciferol 800IU in healthy male subjects
Interventions
DRUGRaloxifene 60mg/Cholecalciferol 800IU
Raloxifene 60mg/Cholecalciferol 800IU tablet
DRUGAD-102
AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit * The Age between 19 and 50 in healthy male volunteers at the time of screening visit
Exclusion criteria
* As a result of laboratory tests, the following figures: ALT or AST\> 2 times upper limit of normal range * As a result of laboratory tests, the following figures: 25-OH vitamin D total \<9 ng/mL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | pre-dose to 96 hours | Cmax of Raloxifene |
| Area under the curve in time plot (AUCt) | pre-dose to 96 hours | AUCt of Raloxifene |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve in time plot (AUCinf) | pre-dose to 96 hours | AUCinf of Raloxifene |
| Time to reach Cmax | pre-dose to 96 hours | Tmax of Raloxifene |
| Effective half-life | pre-dose to 96 hours | t1/2 of Raloxifene |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | From Day 1 until 32 Days | Incidence rate of adverse events |
Countries
South Korea
Outcome results
None listed