A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of DW1809

Phase 1CompletedNCT05214677

Daewon Pharmaceutical Co., Ltd.38 enrolled

Overview

Randomized, Open-label, Oral, Single-dose, two-Sequence, four-Period, crossover study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis Rheumatoid Arthritis Back Pain Acute Upper Respiratory Tract Infection

Interventions

DW1809DRUG

pelubiprofen 30mg

DW1809-1DRUG

pelubiprofen 30mg (PELUBI tab.)

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Volunteers who are ≥19 years old * Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and Exclusion Criteria: * Clinically significant Medical History * In the case of women, pregnant(Urine-HCG positive) or lactating women

Locations (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Pharmacokinetics of Pelubiprofen

Time frame: up to 8 hour

Area under the plasma concentration versus time curve (AUC)

Pharmacokinetics of Pelubiprofen

Time frame: up to 8 hour

Data from ClinicalTrials.gov

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