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

May 26, 2022 updated by: CrystalGenomics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Pregabalin + Polmacoxib
Drug: Polmacoxib
Polmacoxib
Drug: Pregabalin
Pregabalin
Active Comparator: Group B
Polmacoxib
Drug: Polmacoxib
Polmacoxib
Active Comparator: Group C
Pregabalin
Drug: Pregabalin
Pregabalin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CrystalGenomics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

May 19, 2020

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

May 8, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG100651-1-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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