Status:
COMPLETED
Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers
Lead Sponsor:
CrystalGenomics, Inc.
Conditions:
Healthy
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
- Key
Exclusion
- 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)
- Genetically galactose intolerance, lactose intolerance or Glucose-Galactose Malabsorption
- Any other reasons or situations that the investigator decides the patient is not eligible to participate the clinical trial.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03775629
Start Date
December 1 2018
End Date
April 10 2019
Last Update
May 27 2022
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080