Healthy Clinical Trial
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
Verified date | May 2022 |
Source | CrystalGenomics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | April 10, 2019 |
Est. primary completion date | April 4, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
CrystalGenomics, Inc. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUCtau of Polmacoxib and Tramadol | up to 4 weeks | ||
Primary | Cmax of Polmacoxib and Tramadol | up to 4 weeks | ||
Secondary | Cmax of Polmacoxib | up to 4 weeks | ||
Secondary | AUC tau of Polmacoxib | up to 4 weeks | ||
Secondary | Cmax of Tramadol | up to 4 weeks | ||
Secondary | AUCtau of Tramadol | up to 4 weeks |
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