NCT06147908

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2022

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

November 15, 2023

Last Update Submit

November 19, 2023

Conditions

Apetite Stimulants

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    Pharmacokinetics of Megestrol Acetate

    up to 120 hour

  • Area under the plasma concentration versus time curve (AUC)

    Pharmacokinetics of Megestrol Acetate

    up to 120 hour

Study Arms (2)

Sequence A

EXPERIMENTAL

cross-over

Drug: DW5221Drug: DW5221-R

Sequence B

EXPERIMENTAL

cross-over

Drug: DW5221Drug: DW5221-R

Interventions

DW5221DRUG

megestrol acetate

Also known as: Test
Sequence ASequence B
DW5221-RDRUG

megestrol acetate

Also known as: Reference
Sequence ASequence B

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Male Volunteers who are ≥19 years old
  • Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and

You may not qualify if:

  • Clinically significant Medical History

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Related Publications (1)

  • Park SR, Hwang JG, Jeong SI, Choi YS, Min HJ, Kim HY, Choi BH, Park MK. Comparison of the pharmacokinetic characteristics and bioequivalence between two nanosuspension formulations of megestrol acetate in healthy Korean male subjects. Transl Clin Pharmacol. 2024 Mar;32(1):63-72. doi: 10.12793/tcp.2024.32.e6. Epub 2024 Mar 26.

    PMID: 38586120DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 28, 2023

Study Start

July 1, 2022

Primary Completion

October 26, 2022

Study Completion

November 17, 2022

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

KR(1)