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CompletedNCT04375865Updated Nov 6, 2020

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

A Phase 1 interventional study of AD-2111 and AD-2112 in Pain, sponsored by Addpharma Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.

Sponsored by Addpharma Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Pain
03

In context

Lead sponsor

Addpharma Inc. is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Treatment A

    Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg

    Drug: AD-2111 · Drug: AD-2112

  • Experimental
    Treatment B

    Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg

    Drug: AD-2111 · Drug: AD-2112

  • Experimental
    Treatment C

    Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg

    Drug: AD-2111 · Drug: AD-2112

  • Experimental
    Treatment D

    Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg

    Drug: AD-2111 · Drug: AD-2112

  • Experimental
    Treatment E

    Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg

    Drug: AD-2111 · Drug: AD-2112

  • Active comparator
    Treatment F

    Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg

    Drug: AD-2111 · Drug: AD-2112

Interventions

  • DrugAD-2111

    celecoxib 200mg

  • DrugAD-2112

    Tramadol 150mg

06

What researchers measure

Primary outcomes

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

    AUCt of the total ingredient of Celecoxib, Tramadol

    Time frame: pre-dose to 72 hours

  2. Peak Plasma Concentration (Cmax)

    Cmax of the total ingredient of Celecoxib, Tramadol

    Time frame: pre-dose to 72 hours

Secondary outcomes

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

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

    Time frame: pre-dose to 72 hours

  2. Time to reach Cmax(Tmax)

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

    Time frame: pre-dose to 72 hours

  3. Effective half-life(t1/2)

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

    Time frame: pre-dose to 72 hours

  4. Clearance(CL/F)

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

    Time frame: pre-dose to 72 hours

  5. Volume of distribution(Vd/F)

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

    Time frame: pre-dose to 72 hours

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

    AUCt of the total ingredient of O-desmethyltramadol

    Time frame: pre-dose to 72 hours

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

    Cmax of the total ingredient of O-desmethyltramadol

    Time frame: pre-dose to 72 hours

07

Study locations

1 site
  • Kyungpook National University Hospital
    Daegu, 41944, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04375865
Lead sponsor
Addpharma Inc.
Responsible party
Sponsor
First posted
May 6, 2020
Start date
May 30, 2020
Primary completion
Jul 16, 2020
Completion
Jul 16, 2020
Last update
Nov 6, 2020

Study contacts

Young-Ran Yoon, M.D., Ph.D
principal investigator · Kyungpook National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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