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

Addpharma

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: AD-2112; Drug: AD-2111

Study type: Interventional

Funder types: Industry

Identifiers

NCT04375865

AD-211DDI

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 6 patient groups

Treatment A

Experimental group

Description:

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

Treatment:

Drug: AD-2112

Drug: AD-2111

Treatment B

Experimental group

Description:

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

Treatment:

Drug: AD-2112

Drug: AD-2111

Treatment C

Experimental group

Description:

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

Treatment:

Drug: AD-2112

Drug: AD-2111

Treatment D

Experimental group

Description:

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

Treatment:

Drug: AD-2112

Drug: AD-2111

Treatment E

Experimental group

Description:

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

Treatment:

Drug: AD-2112

Drug: AD-2111

Treatment F

Active Comparator group

Description:

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

Treatment:

Drug: AD-2112

Drug: AD-2111