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

• Status: Completed
• Trial end date: 2020-05-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CrystalGenomics, Inc.
• Treatments: Pregabalin

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.