Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03764462

Enrollment

Registered

2018-12-05

Start date

2018-12-14

Completion date

2019-02-08

Last updated

2019-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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

Interventions

DRUGAD-101 45mg

Raloxifene 45mg tablet

DRUGRaloxifene 60mg

Raloxifene 60mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Area under the curve in time plot (AUCt)	pre-dose to 96 hours	AUCt of the total ingredient of AD-101
Peak Plasma Concentration (Cmax)	pre-dose to 96 hours	Cmax of the total ingredient of AD-101

Secondary

Measure	Time frame	Description
Time to reach Cmax	pre-dose to 96 hours	Tmax of the total ingredient of AD-101
Effective half-life	pre-dose to 96 hours	t1/2 of the total ingredient of AD-101
Volume of distribution	pre-dose to 96 hours	Vd/F of the total ingredient of AD-101
Clearance	pre-dose to 96 hours	CL/F of the total ingredient of AD-101
Area under the curve in time plot (AUCinf)	pre-dose to 96 hours	AUCinf of the total ingredient of AD-101

Other

Measure	Time frame	Description
Number of participants with adverse events	From Day 1 until 40 Days	Incidence rate of adverse events

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026