Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03826485

Enrollment

Registered

2019-02-01

Start date

2019-04-01

Completion date

2019-07-31

Last updated

2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Pranlukast hydrate

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

Interventions

DRUGPRIC

Pranlukast hydrate 50mg

DRUGPranlukast hydrate

Pranlukast hydrate 225mg/2.25g

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026