Status:
COMPLETED
Drug-Drug Interaction Study of "CG-651" in Healthy Volunteer
Lead Sponsor:
CrystalGenomics, Inc.
Conditions:
Healthy
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
This is randomized , open-label, multiple-dose, parallel study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG-651" in healthy volunteers.
Detailed Description
Total of 39 health volunteers will be randomized to receive either of Group A,B or C. (13 subjects each) \[Group A\] Pregabalin+ Polmacoxib. \[Group B\] Polmacoxib \[Group C\] Pregabalin
Eligibility Criteria
Inclusion
- Key
- Adequate 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, non specific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti-inflammatory analgesics(including COX-2 inhibitors)
- Any other reason or situations that the investigator decides the patient is not eligible to participate the clinical trial.
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2020
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT05370716
Start Date
November 11 2019
End Date
May 19 2020
Last Update
May 31 2022
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080