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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762397
First Posted: January 7, 2013
Last Update Posted: May 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PharmaKing
December 20, 2012
January 7, 2013
May 30, 2014
December 2012
May 2013   (Final data collection date for primary outcome measure)
  • Safety [ Time Frame: 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 [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01762397 on ClinicalTrials.gov Archive Site
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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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Gastritis
  • Gastric Ulcer
Drug: PMK-S005
Experimental: PMK-S005
Intervention: Drug: PMK-S005
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
Not Provided
May 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01762397
PMK-S005
Not Provided
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PharmaKing
PharmaKing
Not Provided
Not Provided
PharmaKing
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP