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Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers

NCT ID: NCT03824171

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

2019-02-28

Study Completion Date

2019-04-08

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects

Detailed Description

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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

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/Cholecalciferol 800IU to AD-102

Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral

Group Type EXPERIMENTAL

Raloxifene 60mg/Cholecalciferol 800IU

Intervention Type DRUG

Raloxifene 60mg/Cholecalciferol 800IU tablet

AD-102

Intervention Type DRUG

AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet

AD-102 to Raloxifene 60mg/Cholecalciferol 800IU

Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral

Group Type EXPERIMENTAL

Raloxifene 60mg/Cholecalciferol 800IU

Intervention Type DRUG

Raloxifene 60mg/Cholecalciferol 800IU tablet

AD-102

Intervention Type DRUG

AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet

Interventions

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Raloxifene 60mg/Cholecalciferol 800IU

Raloxifene 60mg/Cholecalciferol 800IU tablet

Intervention Type DRUG

AD-102

AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Korea University Guro Hosptial

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-102BE

Identifier Type: -

Identifier Source: org_study_id