Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R

Daewon Pharmaceutical Co., Ltd.54 enrolled

Overview

A bioequivalence study to compare and evaluate the pharmacokinetic characteristics and the safety after administration of DW5221 and DW5221-R in healthy adult m ale volunteers

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Apetite Stimulants

Interventions

DW5221DRUG

megestrol acetate

DW5221-RDRUG

megestrol acetate

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Male 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

Locations (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

Pharmacokinetics of Megestrol Acetate

Time frame: up to 120 hour

Area under the plasma concentration versus time curve (AUC)

Pharmacokinetics of Megestrol Acetate

Time frame: up to 120 hour

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.