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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: AD-2111; Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg	Drug: AD-2111; celecoxib 200mg; Drug: AD-2112; Tramadol 150mg
Experimental: Treatment B; Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg	Drug: AD-2111; celecoxib 200mg; Drug: AD-2112; Tramadol 150mg
Experimental: Treatment C; Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg	Drug: AD-2111; celecoxib 200mg; Drug: AD-2112; Tramadol 150mg
Experimental: Treatment D; Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg	Drug: AD-2111; celecoxib 200mg; Drug: AD-2112; Tramadol 150mg
Experimental: Treatment E; Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg	Drug: AD-2111; celecoxib 200mg; Drug: AD-2112; Tramadol 150mg
Active Comparator: Treatment F; Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg	Drug: AD-2111; celecoxib 200mg; Drug: AD-2112; Tramadol 150mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Addpharma Inc.
• Investigators: Principal Investigator: Young-Ran Yoon, M.D., Ph.D, Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2020
• Primary Completion (Actual): July 16, 2020
• Study Completion (Actual): July 16, 2020

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AD-211DDI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No