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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Polmacoxib and Tramadol combination; Drug: Tramadol hydrochloride; Drug: Polmacoxib

• Registration Number: NCT03775629
• Lead Sponsor: CrystalGenomics, Inc.

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.

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 Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2018-12-09
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-14
• Primary Completion: 2019-04-04
• Study Completion: 2019-04-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polmacoxib and Tramadol combination	Polmacoxib and Tramadol combination	Tramadol + Polmacoxib capsule
Tramadol	Tramadol hydrochloride	Tramadol hydrochloride (HCl)
Polmacoxib	Polmacoxib	Polmacoxib

Primary Outcome Measures

Name	Time	Method
Cmax of Polmacoxib and Tramadol	up to 4 weeks
AUCtau of Polmacoxib and Tramadol	up to 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of