Apetite StimulantsPhase 1NCT06147908
Clinical Trial to Evaluate the Pharmacokinetic Characteristics of DW5221 and DW5221-R
A Phase 1 study testing DW5221 and DW5221-R in people with Apetite Stimulants, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Apetite Stimulants
- What is being tested?
- DW5221 and DW5221-R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2022to 17 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Male Volunteers who are ≥19 years old
- Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and
Who cannot join
- Clinically significant Medical History
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Apetite Stimulants
- Being tested
- DW5221, DW5221-R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW5221Drug
Also called Test
megestrol acetate
DW5221-RDrug
Also called Reference
megestrol acetate
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | cross-over Receives: Drug: DW5221; Drug: DW5221-R |
| Sequence B | Experimental | cross-over Receives: Drug: DW5221; Drug: DW5221-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Pharmacokinetics of Megestrol Acetate
Measured: up to 120 hour
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics of Megestrol Acetate
Measured: up to 120 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Jul 2022
- Primary completion26 Oct 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apetite StimulantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147908
- Sponsor's protocol ID
- DW5221-1
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38586120
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06147908
- Acronym / sponsor ID
- DW5221-1
- Conditions
- Apetite Stimulants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: DW5221, Drug: DW5221-Rcross-over |
| Sequence B | Experimental | Drug: DW5221, Drug: DW5221-Rcross-over |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Male Volunteers who are ≥19 years old
- Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2 and
Key exclusion criteria (1 listed)
- Clinically significant Medical History
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DW5221Also: Testmegestrol acetate | Drug | Sequence A, Sequence B |
| DW5221-RAlso: Referencemegestrol acetate | Drug | Sequence A, Sequence B |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: up to 120 hour
Pharmacokinetics of Megestrol Acetate
Area under the plasma concentration versus time curve (AUC)
Time frame: up to 120 hour
Pharmacokinetics of Megestrol Acetate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 38586120Park 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DW5221 and DW5221-R in people with Apetite Stimulants, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: up to 120 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.