Back to resultsEvaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Raloxifene 60mg/Cholecalciferol 800IU
AD-102
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
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
Sites / Locations
- Korea University Guro Hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Raloxifene 60mg/Cholecalciferol 800IU to AD-102
AD-102 to Raloxifene 60mg/Cholecalciferol 800IU
Arm Description
Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Outcomes
Primary Outcome Measures
Peak Plasma Concentration (Cmax)
Cmax of Raloxifene
Peak Plasma Concentration (Cmax)
Cmax of corrected Cholecalciferol
Area under the curve in time plot (AUCt)
AUCt of Raloxifene
Area under the curve in time plot (AUCt)
AUCt of corrected Cholecalciferol
Secondary Outcome Measures
Area under the curve in time plot (AUCinf)
AUCinf of Raloxifene
Area under the curve in time plot (AUCinf)
AUCinf of Corrected Cholecalciferol
Time to reach Cmax
Tmax of Raloxifene
Time to reach Cmax
Tmax of Corrected Cholecalciferol
Effective half-life
t1/2 of Raloxifene
Effective half-life
t1/2 of Corrected Cholecalciferol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03824171
Brief Title
Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers
Official Title
A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
April 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Raloxifene 60mg/Cholecalciferol 800IU to AD-102
Arm Type
Experimental
Arm Description
Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Arm Title
AD-102 to Raloxifene 60mg/Cholecalciferol 800IU
Arm Type
Experimental
Arm Description
Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Intervention Type
Drug
Intervention Name(s)
Raloxifene 60mg/Cholecalciferol 800IU
Intervention Description
Raloxifene 60mg/Cholecalciferol 800IU tablet
Intervention Type
Drug
Intervention Name(s)
AD-102
Intervention Description
AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Cmax of Raloxifene
Time Frame
pre-dose to 96 hours
Title
Peak Plasma Concentration (Cmax)
Description
Cmax of corrected Cholecalciferol
Time Frame
pre-dose to 72 hours
Title
Area under the curve in time plot (AUCt)
Description
AUCt of Raloxifene
Time Frame
pre-dose to 96 hours
Title
Area under the curve in time plot (AUCt)
Description
AUCt of corrected Cholecalciferol
Time Frame
pre-dose to 72 hours
Secondary Outcome Measure Information:
Title
Area under the curve in time plot (AUCinf)
Description
AUCinf of Raloxifene
Time Frame
pre-dose to 96 hours
Title
Area under the curve in time plot (AUCinf)
Description
AUCinf of Corrected Cholecalciferol
Time Frame
pre-dose to 72 hours
Title
Time to reach Cmax
Description
Tmax of Raloxifene
Time Frame
pre-dose to 96 hours
Title
Time to reach Cmax
Description
Tmax of Corrected Cholecalciferol
Time Frame
pre-dose to 72 hours
Title
Effective half-life
Description
t1/2 of Raloxifene
Time Frame
pre-dose to 96 hours
Title
Effective half-life
Description
t1/2 of Corrected Cholecalciferol
Time Frame
pre-dose to 72 hours
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events
Description
Incidence rate of adverse events
Time Frame
From Day 1 until 32 Days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Korea University Guro Hosptial
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers
We'll reach out to this number within 24 hrs