Drug-Drug Interaction Study of CG-651 in Healthy Volunteer

A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of CG-651 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05370716

Enrollment

Registered

2022-05-11

Start date

2019-11-11

Completion date

2020-05-19

Last updated

2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGPolmacoxib

Polmacoxib

DRUGPregabalin

Pregabalin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

None (open label)

Intervention model description

* Group A: Pregabalin + Polmacoxib * Group B: Polmacoxib * Group C: Pregabalin

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * 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 criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Cmax of polmacoxib and pregabalin	upto 4 weeks	Maximum Observed Plasma Concentration
AUC of polmacoxib and pregabalin	upto 4 weeks	Area Under the Concentration-Time Curve
The Number of Participants Who Experienced Adverse events (AEs)	upto 4 weeks	A non-serious adverse event is any untoward medical occurrence. A serious adverse event is any adverse event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026