NCT03774355

Study to Compare Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers

A Randomized, Open-label, Single, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of "CG1801" and "CGL1802" in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: CrystalGenomics, Inc. · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CG1801	Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.
DRUG	CGL1802	Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2

Timeline

• Start date: 2018-12-17
• Primary completion: 2019-05-03
• Completion: 2019-05-03
• First posted: 2018-12-12
• Last updated: 2019-09-25

Locations

1 site across 1 country: South Korea