Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT03774355
The objective of this open-label, randomized, 2*2 crossover study is to compare the safety and Pharmacokinetics CG1801 and CGL1802 in Healthy Volunteers.
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Notify Me19 year–50 year
All sexes
Interventional
Phase 1
Seoul, 03080, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.
Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2
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
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
Time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
Time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
Time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
Time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
Time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
Time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
Time frame: Day1 pre-dose and each of the post-doses of the 2 treatment periods in CG1801 and CGL1802 Group.
CrystalGenomics, Inc.
Industry
A Randomized, Open-label, Single, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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