A Randomized, Open-label, Single, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- CG1801
- Conditions
- Healthy
- Sponsor
- CrystalGenomics, Inc.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Area Under Curve [AUC]last of polmacoxib AUClast of polmacoxib AUClast of polmacoxib AUClast of polmacoxib
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this open-label, randomized, 2*2 crossover study is to compare the safety and Pharmacokinetics CG1801 and CGL1802 in Healthy Volunteers.
Detailed Description
Healthy volunteers are administrated single-dose over the period I and II (crossover) of CGL1802(Polmacoxib 2mg Tablet) and CG1801(Polmacoxib 2mg capsule) Every time before and after each medication, pharmacokinetic (PK) parameters and safety of CGL1802 and CG1801 is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •After taking a rest in sitting position for 5 minutes, subjects who have blood pressure (90 mmHg ≤ Systolic BP ≤ 139 mmHg, and 60 mmHg ≤ Diastolic BP ≤ 89 mmHg)
- •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
Exclusion Criteria
- •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)
- •Uncontrolled hypertension (over the Systolic BP 140 mm Hg or Diastolic BP 90 mmHG)
- •Edema or Fluid retention
- •AST / ALT \> 1.5 times the normal range including additional and Screening blood tests before randomization.
- •MDRD \< 60mL / min / 1.73m2 including additional and Screening blood tests before randomization.
- •Patient with an active peptic ulcer or gastrointestinal bleeding
- •Patient with inflammatory intestinal disease such as Crohn's disease or ulcerative colitis
- •Patient with Congestive Heart Failure (NYHA II - IV)
Arms & Interventions
CG1801
Dosing 'CG1801' followed by dosing 'CGL1802'
Intervention: CG1801
CGL 1802
Dosing 'CGL1802' followed by dosing 'CG1801'
Intervention: CGL1802
Outcomes
Primary Outcomes
Area Under Curve [AUC]last of polmacoxib AUClast of polmacoxib AUClast of polmacoxib AUClast of polmacoxib
Time Frame: Day1 pre-dose and each of the post-doses of each of the 2 treatment periods in CG1801 and CGL1802 Group.
Area Under Curve \[AUC\]last of CGL1802 will be evaluated
Maximum Plasma Concentration [Cmax] of polmacoxib
Time Frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
Maximum Plasma Concentration \[Cmax\] of CGL1802 will be evaluated
Secondary Outcomes
- Area Under Curve [AUC]last of polmacoxib(Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.)
- AUCinf of polmacoxib(Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.)
- Maximum Plasma Concentration [Cmax] of polmacoxib(Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.)
- Time to maximum plasma concentration [Tmax] of polmacoxib(Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.)
- t1/2 of polmacoxib(Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.)
- clearance [CL/F] of Polmacoxib(Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.)
- Volume of distribution [Vd/F] of Polmacoxib(Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.)