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