NCT03775629

Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers

A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of "CG100650" in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: CrystalGenomics, Inc. · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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 to receive either of Group A, B or C for 14 days (13 subjects each). \[Group A\] Tramadol +Polmacoxib capsule \[Group B\] Polmacoxib capsule \[Group C\] Tramadol Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline; Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and collecting AE, CM by different Group.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Polmacoxib and Tramadol combination	Tramadol hydrochloride , Polmacoxib
DRUG	Polmacoxib	Polmacoxib
DRUG	Tramadol hydrochloride	Tramadol hydrochloride (HCl)

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-04-04
• Completion: 2019-04-10
• First posted: 2018-12-14
• Last updated: 2022-05-27

Locations

1 site across 1 country: South Korea