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Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

Sponsor
SamA Pharmaceutical Co., Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03826485
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
4
Anticipated Duration (Months)
12.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is Safety, Pharmacokinetic Study of PRIC

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers
Anticipated Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Apr 25, 2019
Anticipated Study Completion Date :
Jul 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: A group

Period 1: PRIC Period 2: Pranlukast hydrate

Drug: PRIC
Pranlukast hydrate 50mg
Other Names:
  • PRIC 50mg

    • Drug: Pranlukast hydrate
    Pranlukast hydrate 225mg/2.25g
    Experimental: B group

    Period 1: Pranlukast hydrate Period 2: PRIC

    Drug: PRIC
    Pranlukast hydrate 50mg
    Other Names:
  • PRIC 50mg

    • Drug: Pranlukast hydrate
    Pranlukast hydrate 225mg/2.25g

    Outcome Measures

    Primary Outcome Measures

    1. Area Under the Curve (AUC) to last time point (t) [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

    2. Maximum concentration of drug (Cmax) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Songpa-gu Korea, Republic of

    Sponsors and Collaborators

    • SamA Pharmaceutical Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SamA Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT03826485
    Other Study ID Numbers:
    • PRIC
    First Posted:
    Feb 1, 2019
    Last Update Posted:
    Feb 1, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by SamA Pharmaceutical Co., Ltd
    Pranlukast hydrate
    Additional relevant MeSH terms:
    Pranlukast

    Study Results

    No Results Posted as of Feb 1, 2019