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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05370716
• Other study ID #: CG100651-1-01
• Status: Completed
• Phase: Phase 1
• Start date: November 11, 2019
• Est. completion date: May 19, 2020

Study information

• Verified date: May 2022
• Source: CrystalGenomics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 19, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Polmacoxib
Polmacoxib
• Pregabalin
Pregabalin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CrystalGenomics, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of polmacoxib and pregabalin	Maximum Observed Plasma Concentration	upto 4 weeks
Primary	AUC of polmacoxib and pregabalin	Area Under the Concentration-Time Curve	upto 4 weeks
Primary	The Number of Participants Who Experienced Adverse events (AEs)	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.	upto 4 weeks