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Completed

NCT Number: NCT03824171

Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Guro Hosptial

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Raloxifene 60mg/Cholecalciferol 800IU

Drug

Raloxifene 60mg/Cholecalciferol 800IU tablet

AD-102

Drug

AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: pre-dose to 96 hours

    Cmax of Raloxifene

  2. Peak Plasma Concentration (Cmax)

    Time frame: pre-dose to 72 hours

    Cmax of corrected Cholecalciferol

  3. Area under the curve in time plot (AUCt)

    Time frame: pre-dose to 96 hours

    AUCt of Raloxifene

  4. Area under the curve in time plot (AUCt)

    Time frame: pre-dose to 72 hours

    AUCt of corrected Cholecalciferol

Secondary outcomes

  1. Area under the curve in time plot (AUCinf)

    Time frame: pre-dose to 96 hours

    AUCinf of Raloxifene

  2. Area under the curve in time plot (AUCinf)

    Time frame: pre-dose to 72 hours

    AUCinf of Corrected Cholecalciferol

  3. Time to reach Cmax

    Time frame: pre-dose to 96 hours

    Tmax of Raloxifene

  4. Time to reach Cmax

    Time frame: pre-dose to 72 hours

    Tmax of Corrected Cholecalciferol

  5. Effective half-life

    Time frame: pre-dose to 96 hours

    t1/2 of Raloxifene

  6. Effective half-life

    Time frame: pre-dose to 72 hours

    t1/2 of Corrected Cholecalciferol

Other outcomes

  1. Number of participants with adverse events

    Time frame: From Day 1 until 32 Days

    Incidence rate of adverse events

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of AD-102 in Healthy Male Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2019
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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