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Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-101 45mg
Raloxifene 60mg
Sponsored by
Addpharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kyungpook National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Raloxifene 60mg to AD-101 45mg

AD-101 45mg to Raloxifene 60mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax)
Cmax of the total ingredient of AD-101
Area under the curve in time plot (AUCt)
AUCt of the total ingredient of AD-101

Secondary Outcome Measures

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

Full Information

First Posted
December 3, 2018
Last Updated
August 29, 2019
Sponsor
Addpharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03764462
Brief Title
Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
Official Title
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
January 2, 2019 (Actual)
Study Completion Date
February 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raloxifene 60mg to AD-101 45mg
Arm Type
Experimental
Arm Description
Period 1: Raloxifene 60mg, 1 tab, QD, Per oral / Period 2: AD-101 45mg, 1 tab, QD, Per oral
Arm Title
AD-101 45mg to Raloxifene 60mg
Arm Type
Experimental
Arm Description
Period 1: AD-101 45mg, 1 tab, QD, Per oral / Period 2: Raloxifene 60mg, 1 tab, QD, Per oral
Intervention Type
Drug
Intervention Name(s)
AD-101 45mg
Other Intervention Name(s)
AD-101
Intervention Description
Raloxifene 45mg tablet
Intervention Type
Drug
Intervention Name(s)
Raloxifene 60mg
Intervention Description
Raloxifene 60mg tablet
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Cmax of the total ingredient of AD-101
Time Frame
pre-dose to 96 hours
Title
Area under the curve in time plot (AUCt)
Description
AUCt of the total ingredient of AD-101
Time Frame
pre-dose to 96 hours
Secondary Outcome Measure Information:
Title
Area under the curve in time plot (AUCinf)
Description
AUCinf of the total ingredient of AD-101
Time Frame
pre-dose to 96 hours
Title
Time to reach Cmax
Description
Tmax of the total ingredient of AD-101
Time Frame
pre-dose to 96 hours
Title
Effective half-life
Description
t1/2 of the total ingredient of AD-101
Time Frame
pre-dose to 96 hours
Title
Clearance
Description
CL/F of the total ingredient of AD-101
Time Frame
pre-dose to 96 hours
Title
Volume of distribution
Description
Vd/F of the total ingredient of AD-101
Time Frame
pre-dose to 96 hours
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events
Description
Incidence rate of adverse events
Time Frame
From Day 1 until 40 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Ran Yoon, M.D., Ph.D
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

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