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

Phase 1

Completed

• Conditions: Apetite Stimulants
• Interventions: Drug: DW5221; Drug: DW5221-R

• Registration Number: NCT06147908
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2022-10-26
• Study Completion: 2022-11-17
• Status Verified: 2023-11
• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-19
• Last Update Submitted: 2023-11-19
• Study First Posted: 2023-11-28
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	DW5221-R	cross-over
Sequence A	DW5221	cross-over
Sequence B	DW5221	cross-over
Sequence B	DW5221-R	cross-over

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	up to 120 hour	Pharmacokinetics of Megestrol Acetate
Area under the plasma concentration versus time curve (AUC)	up to 120 hour	Pharmacokinetics of Megestrol Acetate

Trial Locations

Locations (1)

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Korea, Republic of