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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.
Information provided by (Responsible Party):
PharmaKing Identifier:
First received: December 20, 2012
Last updated: May 29, 2014
Last verified: May 2014
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.

Condition Intervention Phase
Gastric Ulcer
Drug: PMK-S005
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by PharmaKing:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 37
Study Start Date: December 2012
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PMK-S005 Drug: PMK-S005


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01762397

Korea, Republic of
Chungnam national university hospital
Daejeon, Chungnam, Korea, Republic of, 301-721
Sponsors and Collaborators
  More Information

Responsible Party: PharmaKing Identifier: NCT01762397     History of Changes
Other Study ID Numbers: PMK-S005
Study First Received: December 20, 2012
Last Updated: May 29, 2014

Additional relevant MeSH terms:
Stomach Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases processed this record on May 25, 2017