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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:
Information provided by (Responsible Party):
PharmaKing
ClinicalTrials.gov Identifier:
NCT01762397
First received: December 20, 2012
Last updated: May 29, 2014
Last verified: May 2014
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762397

Locations
Korea, Republic of
Chungnam national university hospital
Daejeon, Chungnam, Korea, Republic of, 301-721
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: May 29, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Ulcer
Digestive System Diseases
Gastrointestinal Diseases
Peptic Ulcer
Stomach Diseases

ClinicalTrials.gov processed this record on November 27, 2014