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

CrystalGenomics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Polmacoxib and Tramadol combination; Drug: Polmacoxib; Drug: Tramadol hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT03775629

CG100650-1-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Polmacoxib and Tramadol combination

Experimental group

Description:

Tramadol + Polmacoxib capsule

Treatment:

Drug: Polmacoxib and Tramadol combination

Polmacoxib

Active Comparator group

Description:

Polmacoxib

Treatment:

Drug: Polmacoxib

Tramadol

Active Comparator group

Description:

Tramadol hydrochloride (HCl)

Treatment:

Drug: Tramadol hydrochloride