Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Brief Summary:
The purpose of this study is Safety, Pharmacokinetic Study of PRIC

Condition or disease Intervention/treatment Phase
Healthy Drug: PRIC Drug: Pranlukast hydrate 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 25, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: A group
Period 1: PRIC Period 2: Pranlukast hydrate
Drug: PRIC
Pranlukast hydrate 50mg
Other Name: 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 Name: PRIC 50mg

Drug: Pranlukast hydrate
Pranlukast hydrate 225mg/2.25g




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03826485


Locations
Layout table for location information
Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Songpa-gu, Korea, Republic of
Contact: Hyung Suk Lim, MD, Ph.D.         
Sponsors and Collaborators
SamA Pharmaceutical Co., Ltd

Layout table for additonal information
Responsible Party: SamA Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT03826485     History of Changes
Other Study ID Numbers: PRIC
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Pranlukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs