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Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers

Sponsor
CrystalGenomics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03775629
Collaborator
(none)
41
Enrollment
1
Location
3
Arms
4.3
Actual Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized, open-label, multiple-dose, parallel, Phase 1 study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG100650" in healthy volunteers.

Condition or Disease Intervention/Treatment Phase
  • Drug: Polmacoxib and Tramadol combination
  • Drug: Polmacoxib
  • Drug: Tramadol hydrochloride
 Phase 1

Detailed Description

This is a randomized, open label, multiple-dose, parallel study to compare PK and to evaluate Drug-Drug Interaction of CG100650 in healthy volunteers.

Total of 39 health volunteers will be randomized to receive either of Group A, B or C for 14 days (13 subjects each).

[Group A] Tramadol +Polmacoxib capsule [Group B] Polmacoxib capsule [Group C] Tramadol

Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline;

Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and collecting AE, CM by different Group.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Group A: Tramadol hydrochloride +Polmacoxib Group B: Polmacoxib Group C: Tramadol hydrochlorideGroup A: Tramadol hydrochloride +Polmacoxib Group B: Polmacoxib Group C: Tramadol hydrochloride
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of "CG100650" in Healthy Volunteers
Actual Study Start Date :
Dec 1, 2018
Actual Primary Completion Date :
Apr 4, 2019
Actual Study Completion Date :
Apr 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Polmacoxib and Tramadol combination

Tramadol + Polmacoxib capsule

Drug: Polmacoxib and Tramadol combination
Tramadol hydrochloride , Polmacoxib
Active Comparator: Polmacoxib

Polmacoxib

Drug: Polmacoxib
Polmacoxib
Active Comparator: Tramadol

Tramadol hydrochloride (HCl)

Drug: Tramadol hydrochloride
Tramadol hydrochloride (HCl)
Other Names:
  • Tramadol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUCtau of Polmacoxib and Tramadol [up to 4 weeks]

    2. Cmax of Polmacoxib and Tramadol [up to 4 weeks]

    Secondary Outcome Measures

    1. Cmax of Polmacoxib [up to 4 weeks]

    2. AUC tau of Polmacoxib [up to 4 weeks]

    3. Cmax of Tramadol [up to 4 weeks]

    4. AUCtau of Tramadol [up to 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    1. Male or female aged ≥ 19 years and ≤ 50 years

    2. Without inborn or chronic disease and no symptoms in physical examination

    3. BMI(Body Mass Index) result ≥ 18kg/m 2 and ≤ 30kg/m2

    4. Adequate clinical laboratory test results as evidenced by Hematology, Hemostasis, Biochemistry, Urinalysis, Serology and so on

    5. 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

    6. Negative pregnancy test(hCG) and agree to contraception during the trial

    Key Exclusion Criteria:

    1. History of hypersensitivity to investigational products

    2. History of hypersensitivity or allergic reaction to sulfonamide.

    3. Patients with a history of asthma, acute rhinitis, nonspecific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti- inflammatory analgesics (including COX-2 inhibitors)

    4. Genetically galactose intolerance, lactose intolerance or Glucose-Galactose Malabsorption

    5. Any other reasons or situations that the investigator decides the patient is not eligible to participate the clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • CrystalGenomics, Inc.

    Investigators

    • Principal Investigator: Kyung-Sang Yu, Ph.D., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CrystalGenomics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03775629
    Other Study ID Numbers:
    • CG100650-1-01
    First Posted:
    Dec 14, 2018
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tramadol

    Study Results

    No Results Posted as of May 27, 2022