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

PharmaKing

Status and phase

Completed

Phase 1

Conditions

Gastritis

Gastric Ulcer

Treatments

Drug: PMK-S005

Study type

Interventional

Funder types

Industry

Identifiers

NCT01762397

PMK-S005

Details and patient eligibility

About

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.

Enrollment

37 estimated patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.