Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

Phase 1

• Conditions: Healthy
• Interventions: Drug: PRIC; Drug: Pranlukast hydrate

• Registration Number: NCT03826485
• Lead Sponsor: SamA Pharmaceutical Co., Ltd

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

Study Timeline

• Study First Submitted: 2016-12-28
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Study First Posted: 2019-02-01
• Last Update Posted: 2019-02-01
• Study Start: 2019-04-01
• Primary Completion: 2019-04-25
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A group	PRIC	Period 1: PRIC Period 2: Pranlukast hydrate
A group	Pranlukast hydrate	Period 1: PRIC Period 2: Pranlukast hydrate
B group	PRIC	Period 1: Pranlukast hydrate Period 2: PRIC
B group	Pranlukast hydrate	Period 1: Pranlukast hydrate Period 2: PRIC

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, Korea, Republic of