Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers
A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects
1 other identifier
interventional
52
1 country
1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2019
CompletedAugust 30, 2019
August 1, 2019
27 days
January 28, 2019
August 29, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Peak Plasma Concentration (Cmax)
Cmax of Raloxifene
pre-dose to 96 hours
Peak Plasma Concentration (Cmax)
Cmax of corrected Cholecalciferol
pre-dose to 72 hours
Area under the curve in time plot (AUCt)
AUCt of Raloxifene
pre-dose to 96 hours
Area under the curve in time plot (AUCt)
AUCt of corrected Cholecalciferol
pre-dose to 72 hours
Secondary Outcomes (6)
Area under the curve in time plot (AUCinf)
pre-dose to 96 hours
Area under the curve in time plot (AUCinf)
pre-dose to 72 hours
Time to reach Cmax
pre-dose to 96 hours
Time to reach Cmax
pre-dose to 72 hours
Effective half-life
pre-dose to 96 hours
- +1 more secondary outcomes
Other Outcomes (1)
Number of participants with adverse events
From Day 1 until 32 Days
Study Arms (2)
Raloxifene 60mg/Cholecalciferol 800IU to AD-102
EXPERIMENTALPeriod 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
AD-102 to Raloxifene 60mg/Cholecalciferol 800IU
EXPERIMENTALPeriod 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Interventions
Raloxifene 60mg/Cholecalciferol 800IU tablet
AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Addpharma Inc.lead
Study Sites (1)
Korea University Guro Hosptial
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2019
First Posted
January 31, 2019
Study Start
February 28, 2019
Primary Completion
March 27, 2019
Study Completion
April 8, 2019
Last Updated
August 30, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share