Back to resultsA Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
Primary Purpose
Gastritis, Gastric Ulcer
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PMK-S005
Sponsored by
About this trial
This is an interventional treatment trial for Gastritis
Eligibility 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.
Sites / Locations
- Chungnam national university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PMK-S005
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01762397
Brief Title
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaKing
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis, Gastric Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PMK-S005
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PMK-S005
Primary Outcome Measure Information:
Title
Safety
Description
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
Time Frame
8day
Title
Pharmacokinetics
Description
Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2.
Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery
Time Frame
8day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Chungnam national university hospital
City
Daejeon
State/Province
Chungnam
ZIP/Postal Code
301-721
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
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