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

CrystalGenomics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Polmacoxib; Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05370716

CG100651-1-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 47 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

Group A

Experimental group

Description:

Pregabalin + Polmacoxib

Treatment:

Drug: Polmacoxib

Drug: Pregabalin

Group B

Active Comparator group

Description:

Polmacoxib

Treatment:

Drug: Polmacoxib

Group C

Active Comparator group

Description:

Pregabalin

Treatment:

Drug: Pregabalin