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

Phase 1

Completed

• Conditions: Gastritis; Gastric Ulcer
• Interventions: Drug: PMK-S005

• Registration Number: NCT01762397
• Lead Sponsor: PharmaKing

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-07
• Primary Completion: 2013-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMK-S005	PMK-S005	-

Primary Outcome Measures

Name	Time	Method
Safety	8day	1. Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.; 2. Before and after physical examination; 3. Before and after bital Sign: blood pressure, pulse rate, temperature.; 4. Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec.; 5. Lab: hematologic examination, blood coagulation examination,urine examination
Pharmacokinetics	8day	1. Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2.; 2. Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery

Trial Locations

Locations (1)

Chungnam national university hospital; 🇰🇷 Daejeon, Chungnam, Korea, Republic of