HealthyPhase 1NCT03005340
A Phase 1 Drug Drug Interaction Clinical Trial of C1-R215 and C2-R215 in Healthy Male Volunteers
A Phase 1 study testing Treatment B, Treatment C and Treatment BC in people with Healthy, run by Alvogen Korea.
Trial summary
Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215 and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy male volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment B, Treatment C and Treatment BC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jun 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male between 19 and 45
- BW is above 50kg and BMI is between 18.5 and 30.0
- Subject who agreed and signed on informed consent form prior to the study participation
Who cannot join
- Presence or history of clinically significant disease
- Treatment history of any drug which might affect IP within 10days
- History of other study drugs within 12weeks
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Coadministration of C1-R215 and C2-R215 Compared to the Administration of C1-R215 and C2-R215 Independently in Healthy Male Volunteers
Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215 and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy male volunteers
- Conditions
- Healthy
- Being tested
- Treatment B, Treatment C, Treatment BC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment BDrug
Also called Bazedoxifene 20 mg
Bazedoxifene 20 mg
Treatment CDrug
Also called Cholecalciferol granule 10 mg
Cholecalciferol granule 10 mg
Treatment BCDrug
Also called Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Period 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Receives: Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC |
| Group B | Active comparator | Period 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg Receives: Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC |
| Group C | Active comparator | Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Receives: Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC |
| Group D | Active comparator | Period 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg Receives: Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC |
| Group E | Active comparator | Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg Receives: Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC |
| Group F | Active comparator | Period 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg Receives: Drug: Treatment B; Drug: Treatment C; Drug: Treatment BC |
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 Bazedoxifene
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h
Area under the plasma concentration versus time curve(AUCt) of Cholecalciferol
Measured: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h
Peak plasma concentration(Cmax) of Bazedoxifene
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h
Peak plasma concentration(Cmax) of Cholecalciferol
Measured: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Park, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005340
- Sponsor's protocol ID
- AK-CTR215-I-01
- Status last verified
- Dec 2016
- First submitted
- 23 Dec 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Coadministration of C1-R215 and C2-R215 Compared to the Administration of C1-R215 and C2-R215 Independently in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03005340
- Acronym / sponsor ID
- AK-CTR215-I-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Dec 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.
Randomized, open-label, single-dose, three-treatment, six-sequence, three-way crossover study to evaluate the safety and pharmacokinetic characteristics after coadministration of C1-R215 and C2-R215 compared to the administration of C1-R215 and C2-R215 independently in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Treatment B, Drug: Treatment C, Drug: Treatment BCPeriod 1: Bazedoxifene 20 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg |
| Group B | Active comparator | Drug: Treatment B, Drug: Treatment C, Drug: Treatment BCPeriod 1: Bazedoxifene 20 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Cholecalciferol granule 10 mg |
| Group C | Active comparator | Drug: Treatment B, Drug: Treatment C, Drug: Treatment BCPeriod 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg |
| Group D | Active comparator | Drug: Treatment B, Drug: Treatment C, Drug: Treatment BCPeriod 1: Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg |
| Group E | Active comparator | Drug: Treatment B, Drug: Treatment C, Drug: Treatment BCPeriod 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Cholecalciferol granule 10 mg Period 3: Bazedoxifene 20 mg |
| Group F | Active comparator | Drug: Treatment B, Drug: Treatment C, Drug: Treatment BCPeriod 1: Bazedoxifene 20 mg+Cholecalciferol granule 10 mg Period 2: Bazedoxifene 20 mg Period 3: Cholecalciferol granule 10 mg |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male between 19 and 45
- BW is above 50kg and BMI is between 18.5 and 30.0
- Subject who agreed and signed on informed consent form prior to the study participation
Key exclusion criteria (3 listed)
- Presence or history of clinically significant disease
- Treatment history of any drug which might affect IP within 10days
- History of other study drugs within 12weeks
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 |
|---|---|---|
| Treatment BAlso: Bazedoxifene 20 mgBazedoxifene 20 mg | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
| Treatment CAlso: Cholecalciferol granule 10 mgCholecalciferol granule 10 mg | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
| Treatment BCAlso: Bazedoxifene 20 mg, Cholecalciferol granule 10 mgBazedoxifene 20 mg, Cholecalciferol granule 10 mg | 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 Bazedoxifene
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h
Area under the plasma concentration versus time curve(AUCt) of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h
Peak plasma concentration(Cmax) of Bazedoxifene
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h
Peak plasma concentration(Cmax) of Cholecalciferol
Time frame: -24, -12, -6, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Park principal investigator
Dong-A University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment B, Treatment C and Treatment BC 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Dec 2016. 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?
Results are not available in the source record.
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 Bazedoxifene (time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120h). 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?
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 29 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.