HealthyPhase 1NCT03010267
DP-R213 Phase 1 Pharmacokinetics Study
A Phase 1 study testing DP-R213, Raloxifene and Cholecaliferol in people with Healthy, run by Alvogen Korea.
Trial summary
A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DP-R213, Raloxifene and Cholecaliferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2017to 29 Mar 2017
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IBW ±20%
- Signed the informed consent form prior to the study participation
Who cannot join
- Clinically significant disease
- Previously donate whole blood within 2 months or component blood within 1 month
- Clinically significant allergic disease
- Taken IP in other trial within 3 months
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
About this study
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects
A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- DP-R213, Raloxifene, Cholecaliferol
- Keywords
- DP-R213
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP-R213Drug
Investigational product is prescribed to all of randomized subjects
RaloxifeneDrug
Investigational product is prescribed to all of randomized subjects
CholecaliferolDrug
Investigational product is prescribed to all of randomized subjects
| Study group | Role | What they receive |
|---|---|---|
| RT group | Experimental | combination dose of Raloxifene and Cholecaliferol and DP-R213 in order Receives: Drug: DP-R213; Drug: Raloxifene; Drug: Cholecaliferol |
| TR group | Experimental | combination dose of Raloxifene and Cholecaliferol and DP-R213 in order Receives: Drug: DP-R213; Drug: Raloxifene; Drug: Cholecaliferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
Measured: up to 96 hours post dose
Peak Plasma Concentration (Cmax)
Measured: up to 96 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start3 Jan 2017
- Primary completion8 Mar 2017
- Study completion29 Mar 2017
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 HealthyStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010267
- Sponsor's protocol ID
- DP-CTR213-I-04
- Status last verified
- Jun 2017
- First submitted
- 3 Jan 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee HW, Kang WY, Gwon MR, Choi EJ, Kim EH, Cho K, Lee B, Seong SJ, Yoon YR. A randomized, open-label, single-dose, two-way crossover study to assess the pharmacokinetics between two tablets of fixed-dose combination formulation with raloxifene and cholecalciferol and concomitant administration of each agents in healthy male volunteers. Transl Clin Pharmacol. 2022 Sep;30(3):136-144. doi: 10.12793/tcp.2022.30.e13. Epub 2022 Sep 15.
PubMed 36247744
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03010267
- Acronym / sponsor ID
- DP-CTR213-I-04
- Conditions
- Healthy
- Keywords
- DP-R213
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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 randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT group | Experimental | Drug: DP-R213, Drug: Raloxifene, Drug: Cholecaliferolcombination dose of Raloxifene and Cholecaliferol and DP-R213 in order |
| TR group | Experimental | Drug: DP-R213, Drug: Raloxifene, Drug: Cholecaliferolcombination dose of Raloxifene and Cholecaliferol and DP-R213 in order |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IBW ±20%
- Signed the informed consent form prior to the study participation
Key exclusion criteria (5 listed)
- Clinically significant disease
- Previously donate whole blood within 2 months or component blood within 1 month
- Clinically significant allergic disease
- Taken IP in other trial within 3 months
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
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 |
|---|---|---|
| DP-R213Investigational product is prescribed to all of randomized subjects | Drug | RT group, TR group |
| RaloxifeneInvestigational product is prescribed to all of randomized subjects | Drug | RT group, TR group |
| CholecaliferolInvestigational product is prescribed to all of randomized subjects | Drug | RT group, TR group |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: up to 96 hours post dose
Peak Plasma Concentration (Cmax)
Time frame: up to 96 hours post dose
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 5 Jun 2017.
- Derived from this study: PubMed 36247744Lee HW, Kang WY, Gwon MR, Choi EJ, Kim EH, Cho K, Lee B, Seong SJ, Yoon YR. A randomized, open-label, single-dose, two-way crossover study to assess the pharmacokinetics between two tablets of fixed-dose combination formulation with raloxifene and cholecalciferol and concomitant administration of each agents in healthy male volunteers. Transl Clin Pharmacol. 2022 Sep;30(3):136-144. doi: 10.12793/tcp.2022.30.e13. Epub 2022 Sep 15.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DP-R213, Raloxifene and Cholecaliferol in people with Healthy, run by Alvogen 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 5 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Area under the plasma concentration versus time curve (AUC) (time frame: up to 96 hours post dose). 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 NCT03010267, 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 5 Jun 2017.