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Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

NCT ID: NCT03764462

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2019-02-08

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers

Detailed Description

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This study is to evaluate the pharmacokinetic characteristics and safety of AD-101 compared with administration of raloxifen 60 mg in healthy adults

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raloxifene 60mg to AD-101 45mg

Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral

Group Type EXPERIMENTAL

AD-101 45mg

Intervention Type DRUG

Raloxifene 45mg tablet

Raloxifene 60mg

Intervention Type DRUG

Raloxifene 60mg tablet

AD-101 45mg to Raloxifene 60mg

Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral

Group Type EXPERIMENTAL

AD-101 45mg

Intervention Type DRUG

Raloxifene 45mg tablet

Raloxifene 60mg

Intervention Type DRUG

Raloxifene 60mg tablet

Interventions

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AD-101 45mg

Raloxifene 45mg tablet

Intervention Type DRUG

Raloxifene 60mg

Raloxifene 60mg tablet

Intervention Type DRUG

Other Intervention Names

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AD-101

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young-Ran Yoon, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-101BE

Identifier Type: -

Identifier Source: org_study_id