Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Raloxifene 60mg/Cholecalciferol 800IU; Drug: AD-102

• Registration Number: NCT03824171
• Lead Sponsor: Addpharma Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-31
• Study Start: 2019-02-28
• Primary Completion: 2019-03-27
• Study Completion: 2019-04-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AD-102 to Raloxifene 60mg/Cholecalciferol 800IU	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
AD-102 to Raloxifene 60mg/Cholecalciferol 800IU	AD-102	Period 1: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Raloxifene 60mg/Cholecalciferol 800IU to AD-102	Raloxifene 60mg/Cholecalciferol 800IU	Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral
Raloxifene 60mg/Cholecalciferol 800IU to AD-102	AD-102	Period 1: Raloxifene 60mg/Cholecalciferol 800IU, 2 tab, QD, Per oral Period 2: Raloxifene 45mg/Cholecalciferol 800IU, 2 tab, QD, Per oral

Primary Outcome Measures

Name	Time	Method
Area under the curve in time plot (AUCt)	pre-dose to 72 hours	AUCt of corrected Cholecalciferol
Peak Plasma Concentration (Cmax)	pre-dose to 72 hours	Cmax of corrected Cholecalciferol

Secondary Outcome Measures

Name	Time	Method
Effective half-life	pre-dose to 72 hours	t1/2 of Corrected Cholecalciferol
Time to reach Cmax	pre-dose to 72 hours	Tmax of Corrected Cholecalciferol
Area under the curve in time plot (AUCinf)	pre-dose to 72 hours	AUCinf of Corrected Cholecalciferol

Trial Locations

Locations (1)

Korea University Guro Hosptial; 🇰🇷 Seoul, Korea, Republic of