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

NCT ID: NCT06147908

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-11-17

Brief Summary

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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

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Conditions

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Apetite Stimulants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

cross-over

Group Type EXPERIMENTAL

DW5221

Intervention Type DRUG

megestrol acetate

DW5221-R

Intervention Type DRUG

megestrol acetate

Sequence B

cross-over

Group Type EXPERIMENTAL

DW5221

Intervention Type DRUG

megestrol acetate

DW5221-R

Intervention Type DRUG

megestrol acetate

Interventions

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DW5221

megestrol acetate

Intervention Type DRUG

DW5221-R

megestrol acetate

Intervention Type DRUG

Other Intervention Names

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Test Reference

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 38586120 (View on PubMed)

Other Identifiers

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DW5221-1

Identifier Type: -

Identifier Source: org_study_id