Overview

Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Status:
Completed
Trial end date:
2019-02-08
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Addpharma Inc.
Treatments:
AD 101
Raloxifene Hydrochloride
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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