Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: AD-101 45mg; Drug: Raloxifene 60mg

• Registration Number: NCT03764462
• Lead Sponsor: Addpharma Inc.

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

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Study Start: 2018-12-14
• Primary Completion: 2019-01-02
• Study Completion: 2019-02-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

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

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clearance	pre-dose to 96 hours	CL/F of the total ingredient of AD-101
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
Area under the curve in time plot (AUCinf)	pre-dose to 96 hours	AUCinf of the total ingredient of AD-101
Volume of distribution	pre-dose to 96 hours	Vd/F of the total ingredient of AD-101

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of