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Completed

NCT Number: NCT03775629

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

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.

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Key information

Conditions

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

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.

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Male or female aged ≥ 19 years and ≤ 50 years
  • Without inborn or chronic disease and no symptoms in physical examination
  • BMI(Body Mass Index) result ≥ 18kg/m 2 and ≤ 30kg/m2
  • Adequate clinical laboratory test results as evidenced by Hematology, Hemostasis, 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, nonspecific polyps, angioedema, urticaria or allergic reactions to aspirin or other nonsteroidal anti- inflammatory analgesics (including COX-2 inhibitors)
  • Genetically galactose intolerance, lactose intolerance or Glucose-Galactose Malabsorption
  • Any other reasons or situations that the investigator decides the patient is not eligible to participate the clinical trial.

Treatment and study plan

Polmacoxib and Tramadol combination

Drug

Tramadol hydrochloride , Polmacoxib

Polmacoxib

Drug

Polmacoxib

Tramadol Hydrochloride

Drug

Tramadol hydrochloride (HCl)

Other names: Tramadol

Primary outcomes

  1. AUCtau of Polmacoxib and Tramadol

    Time frame: up to 4 weeks

  2. Cmax of Polmacoxib and Tramadol

    Time frame: up to 4 weeks

Secondary outcomes

  1. Cmax of Polmacoxib

    Time frame: up to 4 weeks

  2. AUC tau of Polmacoxib

    Time frame: up to 4 weeks

  3. Cmax of Tramadol

    Time frame: up to 4 weeks

  4. AUCtau of Tramadol

    Time frame: up to 4 weeks

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 "CG100650" in Healthy Volunteers

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
May 27, 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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