Status:
COMPLETED
Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers
Lead Sponsor:
Addpharma Inc.
Conditions:
Osteoporosis
Eligibility:
MALE
19-50 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03824171
Start Date
February 28 2019
End Date
April 8 2019
Last Update
August 30 2019
Active Locations (1)
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1
Korea University Guro Hosptial
Seoul, South Korea