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Completed

NCT Number: NCT05370716

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

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.

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polmacoxib

Drug

Polmacoxib

Pregabalin

Drug

Pregabalin

Primary outcomes

  1. Cmax of polmacoxib and pregabalin

    Time frame: upto 4 weeks

    Maximum Observed Plasma Concentration

  2. AUC of polmacoxib and pregabalin

    Time frame: upto 4 weeks

    Area Under the Concentration-Time Curve

  3. 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.

Sponsors and collaborators

Lead sponsor

CrystalGenomics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 11, 2022
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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