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 in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04375865

Enrollment

Registered

2020-05-06

Start date

2020-05-30

Completion date

2020-07-16

Last updated

2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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

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

Interventions

DRUGAD-2111

celecoxib 200mg

DRUGAD-2112

Tramadol 150mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Area under the curve in time plot (AUCt)	pre-dose to 72 hours	AUCt of the total ingredient of Celecoxib, Tramadol
Peak Plasma Concentration (Cmax)	pre-dose to 72 hours	Cmax of the total ingredient of Celecoxib, Tramadol

Secondary

Measure	Time frame	Description
Effective half-life(t1/2)	pre-dose to 72 hours	t1/2 of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Clearance(CL/F)	pre-dose to 72 hours	CL/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Area under the curve in time plot (AUCinf)	pre-dose to 72 hours	AUCinf of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Area under the curve in time plot (AUCt) of O-desmethyltramadol	pre-dose to 72 hours	AUCt of the total ingredient of O-desmethyltramadol
Peak Plasma Concentration (Cmax) of O-desmethyltramadol	pre-dose to 72 hours	Cmax of the total ingredient of O-desmethyltramadol
Volume of distribution(Vd/F)	pre-dose to 72 hours	Vd/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Time to reach Cmax(Tmax)	pre-dose to 72 hours	Tmax of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026