Drug-Drug Interaction Study of CG100650 in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of CG100650 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03775629

Enrollment

Registered

2018-12-14

Start date

2018-12-01

Completion date

2019-04-10

Last updated

2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Detailed description

This is a randomized, open label, multiple-dose, parallel study to compare PK and to evaluate Drug-Drug Interaction of CG100650 in healthy volunteers. Total of 39 health volunteers will be randomized to receive either of Group A, B or C for 14 days (13 subjects each). \[Group A\] Tramadol +Polmacoxib capsule \[Group B\] Polmacoxib capsule \[Group C\] Tramadol Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline; Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and collecting AE, CM by different Group.

Interventions

DRUGPolmacoxib and Tramadol combination

Tramadol hydrochloride , Polmacoxib

DRUGPolmacoxib

Polmacoxib

DRUGTramadol hydrochloride

Tramadol hydrochloride (HCl)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: 1. Male or female aged ≥ 19 years and ≤ 50 years 2. Without inborn or chronic disease and no symptoms in physical examination 3. BMI(Body Mass Index) result ≥ 18kg/m 2 and ≤ 30kg/m2 4. Adequate clinical laboratory test results as evidenced by Hematology, Hemostasis, Biochemistry, Urinalysis, Serology and so on 5. 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 6. Negative pregnancy test(hCG) and agree to contraception during the trial Key

Exclusion criteria

1. History of hypersensitivity to investigational products 2. History of hypersensitivity or allergic reaction to sulfonamide. 3. 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) 4. Genetically galactose intolerance, lactose intolerance or Glucose-Galactose Malabsorption 5. Any other reasons or situations that the investigator decides the patient is not eligible to participate the clinical trial.

Design outcomes

Primary

Measure	Time frame
AUCtau of Polmacoxib and Tramadol	up to 4 weeks
Cmax of Polmacoxib and Tramadol	up to 4 weeks

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026