HealthyPhase 1NCT02654093
A Drug-drug Interaction Study of DP-R213
A Phase 1 study testing Cholecalciferol, Raloxifene and Cholecalciferol and Raloxifene co-administration in people with Healthy, run by Alvogen Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to learn about the effect of raloxifene on how the body absorbs and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken together. 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?
- Cholecalciferol, Raloxifene and Cholecalciferol and Raloxifene co-administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Mar 2016
- 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
- Healthy male volunteer, age above 19
- The result of Ideal Body Weight(IBW) is not less than -20%, no more than +20%
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
Who cannot join
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment in completion of this clinical study
- Treatment history of other drugs within last 10 days
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungbook National University Hospital
Jung-gu, Daegu, 41940
About this study
Official title: A Randomized, Open-label, Single-dose, 3-period, 6-sequence Crossover Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of Raloxifene, Cholecalciferol in Healthy Korean Male Subjects
The purpose of this study is to learn about the effect of raloxifene on how the body absorbs and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken together.
- Conditions
- Healthy
- Being tested
- Cholecalciferol, Raloxifene, Cholecalciferol and Raloxifene co-administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
RaloxifeneDrug
Cholecalciferol and Raloxifene co-administrationDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene Receives: Drug: Cholecalciferol; Drug: Raloxifene; Drug: Cholecalciferol and Raloxifene co-administration |
| Group B | Experimental | A → C → B Receives: Drug: Cholecalciferol; Drug: Raloxifene; Drug: Cholecalciferol and Raloxifene co-administration |
| Group C | Experimental | B → A → C Receives: Drug: Cholecalciferol; Drug: Raloxifene; Drug: Cholecalciferol and Raloxifene co-administration |
| Group D | Experimental | B → C → A Receives: Drug: Cholecalciferol; Drug: Raloxifene; Drug: Cholecalciferol and Raloxifene co-administration |
| Group E | Experimental | C → A → B Receives: Drug: Cholecalciferol; Drug: Raloxifene; Drug: Cholecalciferol and Raloxifene co-administration |
| Group F | Experimental | C → B → A Receives: Drug: Cholecalciferol; Drug: Raloxifene; Drug: Cholecalciferol and Raloxifene co-administration |
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(AUCt) of raloxifene
Measured: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours
Peak plasma concentration(Cmax) of raloxifene
Measured: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours
AUCt,corr of cholecalciferol
Measured: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
Cmax,corr of cholecalciferol
Measured: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT02654093
- Sponsor's protocol ID
- DP-CTR213-I-02
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2016
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee HW, Kang WY, Jung W, Gwon MR, Cho K, Lee B, Seong SJ, Yoon YR. Pharmacokinetic Drug Interaction Between Raloxifene and Cholecalciferol in Healthy Volunteers. Clin Pharmacol Drug Dev. 2022 May;11(5):623-631. doi: 10.1002/cpdd.1062. Epub 2022 Jan 4.
PubMed 34984851
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, 3-period, 6-sequence Crossover Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of Raloxifene, Cholecalciferol in Healthy Korean Male Subjects
- ClinicalTrials.gov ID
- NCT02654093
- Acronym / sponsor ID
- DP-CTR213-I-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2016 (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.
The purpose of this study is to learn about the effect of raloxifene on how the body absorbs and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken together.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Cholecalciferol, Drug: Raloxifene, Drug: Cholecalciferol and Raloxifene co-administrationA → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene |
| Group B | Experimental | Drug: Cholecalciferol, Drug: Raloxifene, Drug: Cholecalciferol and Raloxifene co-administrationA → C → B |
| Group C | Experimental | Drug: Cholecalciferol, Drug: Raloxifene, Drug: Cholecalciferol and Raloxifene co-administrationB → A → C |
| Group D | Experimental | Drug: Cholecalciferol, Drug: Raloxifene, Drug: Cholecalciferol and Raloxifene co-administrationB → C → A |
| Group E | Experimental | Drug: Cholecalciferol, Drug: Raloxifene, Drug: Cholecalciferol and Raloxifene co-administrationC → A → B |
| Group F | Experimental | Drug: Cholecalciferol, Drug: Raloxifene, Drug: Cholecalciferol and Raloxifene co-administrationC → B → A |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male volunteer, age above 19
- The result of Ideal Body Weight(IBW) is not less than -20%, no more than +20%
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
Key exclusion criteria (2 listed)
- Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment in completion of this clinical study
- Treatment history of other drugs within last 10 days
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 |
|---|---|---|
| Cholecalciferol | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
| Raloxifene | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
| Cholecalciferol and Raloxifene co-administration | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
Primary outcome
Area under the plasma concentration versus time curve(AUCt) of raloxifene
Time frame: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours
Peak plasma concentration(Cmax) of raloxifene
Time frame: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours
AUCt,corr of cholecalciferol
Time frame: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
Cmax,corr of cholecalciferol
Time frame: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
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 11 Mar 2016.
- Derived from this study: PubMed 34984851Lee HW, Kang WY, Jung W, Gwon MR, Cho K, Lee B, Seong SJ, Yoon YR. Pharmacokinetic Drug Interaction Between Raloxifene and Cholecalciferol in Healthy Volunteers. Clin Pharmacol Drug Dev. 2022 May;11(5):623-631. doi: 10.1002/cpdd.1062. Epub 2022 Jan 4.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Cholecalciferol, Raloxifene and Cholecalciferol and Raloxifene co-administration in people with Healthy, run by Alvogen Korea 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 3 inclusion and 2 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 11 Mar 2016. 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?
Area under the plasma concentration versus time curve(AUCt) of raloxifene (time frame: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours). The study lists 4 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 NCT02654093, 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 11 Mar 2016.