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

Gastritis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762397
• Other study ID #: PMK-S005
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2012
• Last updated: May 29, 2014
• Start date: December 2012

Study information

• Verified date: May 2014
• Source: PharmaKing
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Ulcer
• Gastritis
• Stomach Ulcer

Intervention

Drug:
• PMK-S005

Locations

Country	Name	City	State
Korea, Republic of	Chungnam national university hospital	Daejeon	Chungnam

Sponsors (1)

Lead Sponsor	Collaborator
PharmaKing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.; Before and after physical examination; Before and after bital Sign: blood pressure, pulse rate, temperature.; Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec.; Lab: hematologic examination, blood coagulation examination,urine examination	8day	No
Primary	Pharmacokinetics	Blood evaluation variables: Cmax, AUCt (t=48 h), AUC8, tmax, CL/F, t1/2.; Urine evaluation variables: Aet (t=48 h), Ae8, urine recovery	8day	No