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Completed

NCT Number: NCT03586037

Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.

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Key information

Conditions

Hyperlipidemias Cardiovascular Diseases Dyslipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male between 19 and 50 years of age at the time of screening
  • Weight between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2

Exclusion criteria

  • Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine*hematologic, cardiovascular, urinary, psychiatric
  • Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
  • AST, ALT values over than 1.5 times of ULN at screening
  • HDL values less than 35 mg/dL
  • A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test

Treatment and study plan

AD-2011 10/20 mg

Drug

AD-2011 10/20 mg tablet

AD-2012 80mg

Drug

AD-2012 80mg tablet

AD-2011 10/20 mg + AD-2012 80mg

Drug

AD-2011 10/20 mg + AD-2012 80mg tablet

Primary outcomes

  1. Peak Plasma Concentration

    Time frame: pre-dose to 24 hours

    Cmax of the total ingredient of AD-2011 and AD-2012

  2. Area under the plasma concentration versus time curve

    Time frame: pre-dose to 24 hours

    AUCtau of the total ingredient of AD-2011 and AD-2012

Secondary outcomes

  1. Time to reach Cmax

    Time frame: pre-dose to 24 hours

    Tmax of the total ingredient of AD-2011 and AD-2012

  2. Concentration

    Time frame: pre-dose to 24 hours

    Ctrough of the total ingredient of AD-2011 and AD-2012

  3. Elimination half-life

    Time frame: pre-dose to 24 hours

    t1/2 of the total ingredient of AD-2011 and AD-2012

  4. Clearance

    Time frame: pre-dose to 24 hours

    CL/F of the total ingredient of AD-2011 and AD-2012

  5. Volume of distribution

    Time frame: pre-dose to 24 hours

    Vd/F of the total ingredient of AD-2011 and AD-2012

  6. Number of participants with adverse events

    Time frame: From Day 1 up to Day 45

    Incidence rate of adverse events

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

An Open-label, Sequence-randomized, Three-period, Six-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in Healthy Male Volunteers

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2018
Registry last updated
Oct 9, 2018

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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