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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: AD-2111; Drug: AD-2112

• Registration Number: NCT04375865
• Lead Sponsor: Addpharma Inc.

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

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-06
• Study Start: 2020-05-30
• Primary Completion: 2020-07-16
• Study Completion: 2020-07-16
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B	AD-2112	Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg
Treatment C	AD-2111	Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg
Treatment C	AD-2112	Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg
Treatment B	AD-2111	Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg
Treatment A	AD-2111	Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg
Treatment A	AD-2112	Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg
Treatment E	AD-2112	Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg
Treatment F	AD-2111	Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg
Treatment F	AD-2112	Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg
Treatment D	AD-2111	Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg
Treatment D	AD-2112	Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg
Treatment E	AD-2111	Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Area under the curve in time plot (AUCinf)	pre-dose to 72 hours	AUCinf 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
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
Volume of distribution(Vd/F)	pre-dose to 72 hours	Vd/F 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

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of