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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastritis; Gastric Ulcer
• Intervention / Treatment: Drug: PMK-S005

• Study Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chungnam
    • Daejeon, Chungnam, Korea, Republic of, 301-721
      • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PMK-S005	Drug: PMK-S005

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pharmacokinetics	Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2.; Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery	8day

Collaborators and Investigators

• Sponsor: PharmaKing

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Estimate): May 30, 2014
• Last Update Submitted That Met QC Criteria: May 29, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Gastritis; Stomach Ulcer
• Other Study ID Numbers: PMK-S005