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Evaluating the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers

Sponsor
Addpharma Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03764462
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
1.8
Actual Duration (Months)
28.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-101 in healthy volunteers

Condition or Disease Intervention/Treatment Phase
  • Drug: AD-101 45mg
  • Drug: Raloxifene 60mg
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of AD-101 in Healthy Volunteers
Actual Study Start Date :
Dec 14, 2018
Actual Primary Completion Date :
Jan 2, 2019
Actual Study Completion Date :
Feb 8, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Raloxifene 60mg to AD-101 45mg

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

Drug: AD-101 45mg
Raloxifene 45mg tablet
Other Names:
  • AD-101

    • Drug: Raloxifene 60mg
    Raloxifene 60mg tablet
    Experimental: AD-101 45mg to Raloxifene 60mg

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

    Drug: AD-101 45mg
    Raloxifene 45mg tablet
    Other Names:
  • AD-101

    • Drug: Raloxifene 60mg
    Raloxifene 60mg tablet

    Outcome Measures

    Primary Outcome Measures

    1. Peak Plasma Concentration (Cmax) [pre-dose to 96 hours]

      Cmax of the total ingredient of AD-101

    2. Area under the curve in time plot (AUCt) [pre-dose to 96 hours]

      AUCt of the total ingredient of AD-101

    Secondary Outcome Measures

    1. Area under the curve in time plot (AUCinf) [pre-dose to 96 hours]

      AUCinf of the total ingredient of AD-101

    2. Time to reach Cmax [pre-dose to 96 hours]

      Tmax of the total ingredient of AD-101

    3. Effective half-life [pre-dose to 96 hours]

      t1/2 of the total ingredient of AD-101

    4. Clearance [pre-dose to 96 hours]

      CL/F of the total ingredient of AD-101

    5. Volume of distribution [pre-dose to 96 hours]

      Vd/F of the total ingredient of AD-101

    Other Outcome Measures

    1. Number of participants with adverse events [From Day 1 until 40 Days]

      Incidence rate of adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kyungpook National University Hospital Daegu Korea, Republic of 41944

    Sponsors and Collaborators

    • Addpharma Inc.

    Investigators

    • Principal Investigator: Young-Ran Yoon, M.D., Ph.D, Kyungpook National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Addpharma Inc.
    ClinicalTrials.gov Identifier:
    NCT03764462
    Other Study ID Numbers:
    • AD-101BE
    First Posted:
    Dec 5, 2018
    Last Update Posted:
    Aug 30, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoporosis
    Raloxifene Hydrochloride
    AD 101

    Study Results

    No Results Posted as of Aug 30, 2019