Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

SamA Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Pranlukast hydrate; Drug: PRIC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03826485

PRIC

Details and patient eligibility

About

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

Full description

1. To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup
2. To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup

Enrollment: 48 estimated patients

Sex: Male

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

A group

Experimental group

Description:

Period 1: PRIC Period 2: Pranlukast hydrate

Treatment:

Drug: Pranlukast hydrate

Drug: PRIC

B group

Experimental group

Description:

Period 1: Pranlukast hydrate Period 2: PRIC

Treatment:

Drug: Pranlukast hydrate

Drug: PRIC