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

A Bioequivalence Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Administration of DW5221 and DW5221-R in Healthy Adult Male Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06147908
Enrollment
54
Registered
2023-11-28
Start date
2022-07-01
Completion date
2022-11-17
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apetite Stimulants

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

Interventions

DRUGDW5221

megestrol acetate

DRUGDW5221-R

megestrol acetate

Sponsors

Daewon Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Peak Plasma Concentration (Cmax)up to 120 hourPharmacokinetics of Megestrol Acetate
Area under the plasma concentration versus time curve (AUC)up to 120 hourPharmacokinetics of Megestrol Acetate

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026