A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.

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

Details

• Lead Sponsor: PharmaKing

Criteria

Inclusion Criteria:

• Male 20 year ≤ age ≤ 40 year.

• Weight ≥ 55kg, IBW ±20%.

• Patients with normal hematology, biochemistry, urinary result.

• Patients who have not congenital or chronic disease.

• Provision of written informed consent voluntarily.

Exclusion Criteria:

• Patients having known hypersensitivity to any component of the study drug.

• Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.

• Patients with any gastrointestinal disorders.

• Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg.

• Drug abuser, alcoholic.

• Patients taking ETC medication within 14 days, OTC within 7 days.

• Patients taking other investigational product within 60 days prior to the participation in the study.