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NCT Number: NCT01762397

A 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.

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Key information

Conditions

Gastritis Digestive System Diseases Duodenal Diseases Gastric Ulcer Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chungnam national university hospital

Daejeon, Chungcheongnam-do, 301-721, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PMK-S005

Drug

Primary outcomes

  1. Safety

    Time frame: 8day

    • Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
    • Before and after physical examination
    • Before and after bital Sign: blood pressure, pulse rate, temperature.
    • Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec.
    • Lab: hematologic examination, blood coagulation examination,urine examination

  2. Pharmacokinetics

    Time frame: 8day

    • Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2.
    • Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery

Sponsors and collaborators

Lead sponsor

PharmaKing

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
First posted
Jan 7, 2013
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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