A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Raloxifene 60mg/Cholecalciferol 800IU
- Conditions
- Osteoporosis
- Sponsor
- Addpharma Inc.
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Peak Plasma Concentration (Cmax)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Raloxifene 60mg/Cholecalciferol 800IU to AD-102
Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Intervention: Raloxifene 60mg/Cholecalciferol 800IU
Raloxifene 60mg/Cholecalciferol 800IU to AD-102
Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Intervention: AD-102
AD-102 to Raloxifene 60mg/Cholecalciferol 800IU
Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Intervention: Raloxifene 60mg/Cholecalciferol 800IU
AD-102 to Raloxifene 60mg/Cholecalciferol 800IU
Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Intervention: AD-102
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax)
Time Frame: pre-dose to 72 hours
Cmax of corrected Cholecalciferol
Area under the curve in time plot (AUCt)
Time Frame: pre-dose to 72 hours
AUCt of corrected Cholecalciferol
Secondary Outcomes
- Effective half-life(pre-dose to 72 hours)
- Time to reach Cmax(pre-dose to 72 hours)
- Area under the curve in time plot (AUCinf)(pre-dose to 72 hours)