Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

January 30, 2019 updated by: SamA Pharmaceutical Co., Ltd

A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
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
0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SamA Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

April 25, 2019

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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