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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

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ClinicalTrials.gov Identifier: NCT01762397
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Gastritis Gastric Ulcer Drug: PMK-S005 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : December 2012
Primary Completion Date : May 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: PMK-S005 Drug: PMK-S005


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762397


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

Responsible Party: PharmaKing
ClinicalTrials.gov Identifier: NCT01762397     History of Changes
Other Study ID Numbers: PMK-S005
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Gastritis
Stomach Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases