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Completed

NCT Number: NCT04375865

Evaluating the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112

A phase I clinical trial to evaluate the pharmacokinetic interactions and safety between AD-2111 and AD-2112

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyungpook National University Hospital

Daegu, 41944, South Korea

About this study

Purpose: pharmacokinetic interactions and safety of AD-2111 and AD-2112 in healthy adult volunteers Condition or disease : Pain Intervention/treatment Drug : AD-2111(Celecoxib 200mg), AD-2112(Tramadol 150mg) Phase : Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Adult aged 19 and more at the time of screening visit
  • Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit

Exclusion criteria

  • As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range
  • As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min

Treatment and study plan

AD-2111

Drug

celecoxib 200mg

AD-2112

Drug

Tramadol 150mg

Primary outcomes

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

    Time frame: pre-dose to 72 hours

    AUCt of the total ingredient of Celecoxib, Tramadol

  2. Peak Plasma Concentration (Cmax)

    Time frame: pre-dose to 72 hours

    Cmax of the total ingredient of Celecoxib, Tramadol

Secondary outcomes

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

    Time frame: pre-dose to 72 hours

    AUCinf of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol

  2. Time to reach Cmax(Tmax)

    Time frame: pre-dose to 72 hours

    Tmax of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol

  3. Effective half-life(t1/2)

    Time frame: pre-dose to 72 hours

    t1/2 of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol

  4. Clearance(CL/F)

    Time frame: pre-dose to 72 hours

    CL/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol

  5. Volume of distribution(Vd/F)

    Time frame: pre-dose to 72 hours

    Vd/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol

  6. Area under the curve in time plot (AUCt) of O-desmethyltramadol

    Time frame: pre-dose to 72 hours

    AUCt of the total ingredient of O-desmethyltramadol

  7. Peak Plasma Concentration (Cmax) of O-desmethyltramadol

    Time frame: pre-dose to 72 hours

    Cmax of the total ingredient of O-desmethyltramadol

Sponsors and collaborators

Lead sponsor

Addpharma Inc.

Industry

Registry information

Official study title

A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112 in Healthy Adult Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 6, 2020
Registry last updated
Nov 6, 2020

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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