NCT03826485

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2016

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

24 days

First QC Date

December 28, 2016

Last Update Submit

January 30, 2019

Conditions

Healthy

Keywords

Pranlukast hydrate

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve (AUC) to last time point (t)

    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)

    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

Study Arms (2)

A group

EXPERIMENTAL

Period 1: PRIC Period 2: Pranlukast hydrate

Drug: PRICDrug: Pranlukast hydrate

B group

EXPERIMENTAL

Period 1: Pranlukast hydrate Period 2: PRIC

Drug: PRICDrug: Pranlukast hydrate

Interventions

PRICDRUG

Pranlukast hydrate 50mg

Also known as: PRIC 50mg
A groupB group
Pranlukast hydrateDRUG

Pranlukast hydrate 225mg/2.25g

A groupB group

Eligibility Criteria

Age19 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2016

First Posted

February 1, 2019

Study Start

April 1, 2019

Primary Completion

April 25, 2019

Study Completion

July 31, 2019

Last Updated

February 1, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)