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Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT03826485
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
SamA Pharmaceutical Co., Ltd

Tracking Information
First Submitted Date  ICMJE December 28, 2016
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date February 1, 2019
Estimated Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Area Under the Curve (AUC) to last time point (t) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose ]
    Area under the PRIC/Pranlukast dry syrup concentration in blood-time curve from zero to the final
  • Maximum concentration of drug (Cmax) [ Time Frame: 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose ]
    The maximum PRIC/Pranlukast dry syrup concentration in blood sampling time t
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects
Official Title  ICMJE A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers
Brief Summary The purpose of this study is Safety, Pharmacokinetic Study of PRIC
Detailed Description
  1. To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup
  2. To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PRIC
    Pranlukast hydrate 50mg
    Other Name: PRIC 50mg
  • Drug: Pranlukast hydrate
    Pranlukast hydrate 225mg/2.25g
Study Arms  ICMJE
  • Experimental: A group
    Period 1: PRIC Period 2: Pranlukast hydrate
    Interventions:
    • Drug: PRIC
    • Drug: Pranlukast hydrate
  • Experimental: B group
    Period 1: Pranlukast hydrate Period 2: PRIC
    Interventions:
    • Drug: PRIC
    • Drug: Pranlukast hydrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2019)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date April 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 19 to 45 years old healthy male subject at the screening
  • Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study

Exclusion Criteria:

  • Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
  • Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03826485
Other Study ID Numbers  ICMJE PRIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SamA Pharmaceutical Co., Ltd
Study Sponsor  ICMJE SamA Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SamA Pharmaceutical Co., Ltd
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP