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

This study is currently recruiting participants.
Verified January 2013 by PharmaKing
Sponsor:
Information provided by (Responsible Party):
PharmaKing
ClinicalTrials.gov Identifier:
NCT01762397
First received: December 20, 2012
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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
Gastritis
Gastric Ulcer
Drug: PMK-S005
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PMK-S005 Drug: PMK-S005

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762397

Locations
Korea, Republic of
Chungnam national university hospital Recruiting
Daejeon, Chungnam, Korea, Republic of, 301-721
Contact: Jae-Eun Kim    (+82) 31-739-3349    loveje00@gmail.com   
Sponsors and Collaborators
PharmaKing
  More Information

No publications provided

Responsible Party: PharmaKing
ClinicalTrials.gov Identifier: NCT01762397     History of Changes
Other Study ID Numbers: PMK-S005
Study First Received: December 20, 2012
Last Updated: January 4, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Gastritis
Stomach Ulcer
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Peptic Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014