Status:
COMPLETED
Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
Lead Sponsor:
Addpharma Inc.
Conditions:
Osteoporosis
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers
Detailed Description
This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults
Eligibility Criteria
Inclusion
- Healthy Adult aged 19 and more at the time of screening visit
- Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
- No evidence of medical symptoms or signs of congenital or no chronic disease within the last 3 years as a result of medical examination
Exclusion
- Evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, nerve or allergic disease (except for asymptomatic seasonal allergy untreated at the time of administration)
- History of gastrointestinal disorders (esophageal ataxia or esophageal strictures, Crohn's disease, etc.) or surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of drugs
- As a result of laboratory tests, the following figures: ALT or AST\> 2 times upper limit of normal range
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03764462
Start Date
December 14 2018
End Date
February 8 2019
Last Update
August 30 2019
Active Locations (1)
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1
Kyungpook National University Hospital
Daegu, South Korea, 41944