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

NCT ID: NCT04375865

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-30

Study Completion Date

2020-07-16

Brief Summary

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

Detailed Description

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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

Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment A

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

Group Type EXPERIMENTAL

AD-2111

Intervention Type DRUG

celecoxib 200mg

AD-2112

Intervention Type DRUG

Tramadol 150mg

Treatment B

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

Group Type EXPERIMENTAL

AD-2111

Intervention Type DRUG

celecoxib 200mg

AD-2112

Intervention Type DRUG

Tramadol 150mg

Treatment C

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

Group Type EXPERIMENTAL

AD-2111

Intervention Type DRUG

celecoxib 200mg

AD-2112

Intervention Type DRUG

Tramadol 150mg

Treatment D

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

Group Type EXPERIMENTAL

AD-2111

Intervention Type DRUG

celecoxib 200mg

AD-2112

Intervention Type DRUG

Tramadol 150mg

Treatment E

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

Group Type EXPERIMENTAL

AD-2111

Intervention Type DRUG

celecoxib 200mg

AD-2112

Intervention Type DRUG

Tramadol 150mg

Treatment F

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

Group Type ACTIVE_COMPARATOR

AD-2111

Intervention Type DRUG

celecoxib 200mg

AD-2112

Intervention Type DRUG

Tramadol 150mg

Interventions

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AD-2111

celecoxib 200mg

Intervention Type DRUG

AD-2112

Tramadol 150mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young-Ran Yoon, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-211DDI

Identifier Type: -

Identifier Source: org_study_id