Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers

NCT03775629 | Completed Phase 1 DMC

• 1 other identifier: CG100650-1-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, multiple-dose, parallel, Phase 1 study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG100650" in healthy volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCtau of Polmacoxib and Tramadol

  up to 4 weeks

• Cmax of Polmacoxib and Tramadol

  up to 4 weeks

Secondary Outcomes (4)

• Cmax of Polmacoxib

  up to 4 weeks

• AUC tau of Polmacoxib

  up to 4 weeks

• Cmax of Tramadol

  up to 4 weeks

• AUCtau of Tramadol

  up to 4 weeks

Study Arms (3)

Polmacoxib and Tramadol combination

EXPERIMENTAL

Tramadol + Polmacoxib capsule

Drug: Polmacoxib and Tramadol combination

Polmacoxib

ACTIVE COMPARATOR

Polmacoxib

Drug: Polmacoxib

Tramadol

ACTIVE COMPARATOR

Tramadol hydrochloride (HCl)

Drug: Tramadol hydrochloride

Interventions

Polmacoxib and Tramadol combination DRUG

Tramadol hydrochloride , Polmacoxib

Polmacoxib and Tramadol combination

Polmacoxib DRUG

Polmacoxib

Polmacoxib

Tramadol hydrochloride DRUG

Tramadol hydrochloride (HCl)

Also known as: Tramadol

Tramadol

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged ≥ 19 years and ≤ 50 years
• Without inborn or chronic disease and no symptoms in physical examination
• BMI(Body Mass Index) result ≥ 18kg/m 2 and ≤ 30kg/m2
• Adequate clinical laboratory test results as evidenced by Hematology, Hemostasis, Biochemistry, Urinalysis, Serology and so on
• Subject who understand the objective, method of the study and the characteristics of investigational drug and expected adverse events and provide written informed consent prior to study participation
• Negative pregnancy test(hCG) and agree to contraception during the trial

You may not qualify if:

• History of hypersensitivity to investigational products
• History of hypersensitivity or allergic reaction to sulfonamide.
• Patients with a history of asthma, acute rhinitis, nonspecific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti- inflammatory analgesics (including COX-2 inhibitors)
• Genetically galactose intolerance, lactose intolerance or Glucose-Galactose Malabsorption
• Any other reasons or situations that the investigator decides the patient is not eligible to participate the clinical trial.

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

CG100649; Tramadol

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Kyung-Sang Yu, Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Group A: Tramadol hydrochloride +Polmacoxib Group B: Polmacoxib Group C: Tramadol hydrochloride

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 14, 2018
• Study Start: December 1, 2018
• Primary Completion: April 4, 2019
• Study Completion: April 10, 2019
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

KR (1)