Last reviewed · How we verify

NCT06147908

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

Completed Phase 1 Last updated 28 November 2023
What this trial tests

Phase 1 trial testing DW5221 in Apetite Stimulants in 54 participants. Completed in 17 November 2022.

Timeline
1 July 2022
Primary endpoint
26 October 2022
17 November 2022

Quick facts

Lead sponsorDaewon Pharmaceutical Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment54
Start date1 July 2022
Primary completion26 October 2022
Estimated completion17 November 2022
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Daewon Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 19 to 55, male only, with Apetite Stimulants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Drug Nanocrystals in Oral Absorption: Factors That Influence Pharmacokinetics.
    Macedo LO, Masiero JF, Bou-Chacra NA. · · 2024 · cited 8× · PMID 39339178 · DOI 10.3390/pharmaceutics16091141
  2. Comparison of the pharmacokinetic characteristics and bioequivalence between two nanosuspension formulations of megestrol acetate in healthy Korean male subjects.
    Park SR, Hwang JG, Jeong SI, Choi YS, et al · · 2024 · cited 1× · PMID 38586120 · DOI 10.12793/tcp.2024.32.e6

Verify or expand the search:

Other Daewon Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06147908.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing