Clinical trial NCT03775629: Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers
Official title: A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of "CG100650" in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CrystalGenomics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-14
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A: Tramadol hydrochloride +Polmacoxib Group B: Polmacoxib Group C: Tramadol hydrochloride
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: AUCtau of Polmacoxib and Tramadol
timeFrame: up to 4 weeks
measure: Cmax of Polmacoxib and Tramadol
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Cmax of Polmacoxib
timeFrame: up to 4 weeks
measure: AUC tau of Polmacoxib
timeFrame: up to 4 weeks
measure: Cmax of Tramadol
timeFrame: up to 4 weeks
measure: AUCtau of Tramadol
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: