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

NCT ID: NCT05370716

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-11

Study Completion Date

2020-05-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* Group A: Pregabalin + Polmacoxib
* Group B: Polmacoxib
* Group C: Pregabalin
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None (open label)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Pregabalin + Polmacoxib

Group Type EXPERIMENTAL

Polmacoxib

Intervention Type DRUG

Polmacoxib

Pregabalin

Intervention Type DRUG

Pregabalin

Group B

Polmacoxib

Group Type ACTIVE_COMPARATOR

Polmacoxib

Intervention Type DRUG

Polmacoxib

Group C

Pregabalin

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

Pregabalin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polmacoxib

Polmacoxib

Intervention Type DRUG

Pregabalin

Pregabalin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CrystalGenomics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CG100651-1-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.