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

A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Polmacoxib; Drug: Polmacoxib and Tramadol combination; Drug: Tramadol hydrochloride

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polmacoxib and Tramadol combination; Tramadol + Polmacoxib capsule	Drug: Polmacoxib and Tramadol combination; Tramadol hydrochloride , Polmacoxib
Active Comparator: Polmacoxib	Drug: Polmacoxib; Polmacoxib
Active Comparator: Tramadol; Tramadol hydrochloride (HCl)	Drug: Tramadol hydrochloride; Tramadol hydrochloride (HCl); Other Names: Tramadol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCtau of Polmacoxib and Tramadol	up to 4 weeks
Cmax of Polmacoxib and Tramadol	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax of Polmacoxib	up to 4 weeks
AUC tau of Polmacoxib	up to 4 weeks
Cmax of Tramadol	up to 4 weeks
AUCtau of Tramadol	up to 4 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): April 4, 2019
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: December 9, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: CG100650-1-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No