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Completed

NCT Number: NCT04600284

Evaluating the Pharmacokinetic Interaction Between AD-2101 and AD-2102

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Guro Hospital

Seoul, South Korea

About this study

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.

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 above 50 kg and body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2

Exclusion criteria

  • Clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric
  • Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
  • A person who has a history of drug abuse
  • AST, ALT, Total bilirubin values over than 2 times of UNL at screening
  • Creatinine clearance under 80mL/min

Treatment and study plan

AD-2101

Drug

AD-2101 16/5mg

AD-2102

Drug

AD-2102 25mg

AD-2101 + AD-2102

Drug

AD-2101 16/5mg + AD-2102 25mg

Primary outcomes

  1. Peak Plasma Concentration

    Time frame: pre-dose to 24 hours

    Cmax,ss of the total ingredient of AD-2101 and AD-2102

  2. Area under the plasma concentration versus time curve

    Time frame: pre-dose to 24 hours

    AUCt,ss of the total ingredient of AD-2101 and AD-2102

Secondary outcomes

  1. Time to reach Cmax

    Time frame: pre-dose to 24 hours

    Tmax,ss of the total ingredient of AD-2101 and AD-2102

  2. Clearance

    Time frame: pre-dose to 24 hours

    CLss/F of the total ingredient of AD-2101 and AD-2102

  3. Bottom Plasma Concentration

    Time frame: pre-dose to 24 hours

    Cmin,ss of the total ingredient of AD-2101 and AD-2102

  4. Number of participants with adverse events

    Time frame: From Day 1 up to Day 66

    Incidence rate of adverse events

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2020
Registry last updated
Jul 21, 2021

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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