Clinical Trials Logo
  1. Home
  2. Pain
  3. NCT04375865
  4. Details
NCT04375865 Clinical Trial

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

Pain Clinical Trial

Official title:
A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04375865
Other study ID # AD-211DDI
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 30, 2020
Est. completion date July 16, 2020

Study information
Verified date November 2020
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 16, 2020
Est. primary completion date July 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-2111
celecoxib 200mg
• AD-2112
Tramadol 150mg

Locations
Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the curve in time plot (AUCt) AUCt of the total ingredient of Celecoxib, Tramadol pre-dose to 72 hours
Primary Peak Plasma Concentration (Cmax) Cmax of the total ingredient of Celecoxib, Tramadol pre-dose to 72 hours
Secondary Area under the curve in time plot (AUCinf) AUCinf of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol pre-dose to 72 hours
Secondary Time to reach Cmax(Tmax) Tmax of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol pre-dose to 72 hours
Secondary Effective half-life(t1/2) t1/2 of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol pre-dose to 72 hours
Secondary Clearance(CL/F) CL/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol pre-dose to 72 hours
Secondary Volume of distribution(Vd/F) Vd/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol pre-dose to 72 hours
Secondary Area under the curve in time plot (AUCt) of O-desmethyltramadol AUCt of the total ingredient of O-desmethyltramadol pre-dose to 72 hours
Secondary Peak Plasma Concentration (Cmax) of O-desmethyltramadol Cmax of the total ingredient of O-desmethyltramadol pre-dose to 72 hours
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care