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

NCT ID: NCT03775629

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-04-10

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Polmacoxib and Tramadol combination

Tramadol + Polmacoxib capsule

Group Type: EXPERIMENTAL

Polmacoxib and Tramadol combination

Intervention Type: DRUG

Tramadol hydrochloride , Polmacoxib

Polmacoxib

Polmacoxib

Group Type: ACTIVE_COMPARATOR

Polmacoxib

Intervention Type: DRUG

Polmacoxib

Tramadol

Tramadol hydrochloride (HCl)

Group Type: ACTIVE_COMPARATOR

Tramadol hydrochloride

Intervention Type: DRUG

Tramadol hydrochloride (HCl)

Interventions

Polmacoxib and Tramadol combination

Tramadol hydrochloride , Polmacoxib

Intervention Type: DRUG

Polmacoxib

Polmacoxib

Intervention Type: DRUG

Tramadol hydrochloride

Tramadol hydrochloride (HCl)

Intervention Type: DRUG

Other Intervention Names

Tramadol

Eligibility Criteria

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

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CrystalGenomics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung-Sang Yu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CG100650-1-01

Identifier Type: -

Identifier Source: org_study_id