HealthyPhase 1NCT03321318
AK-R215 Pharmacokinetic Study Phase I
A Phase 1 study testing AK-R215, Bazedoxifene 20 mg and Cholecalciferol 800IU in people with Healthy, run by Alvogen Korea at 1 site in South Korea.
Trial summary
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AK-R215, Bazedoxifene 20 mg and Cholecalciferol 800IU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2017to 12 Jan 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AK-R215 Pharmacokinetic Study Pharmacokinetic Characteristics of AK-R215 in Comparison to Each Component Coadministered in Healthy Adult Male or Menopausal Female Valunteers.
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215
Read the detailed description
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of AK-R215 in healthy adult male or menopausal female volunteers
- Conditions
- Healthy
- Being tested
- AK-R215, Bazedoxifene 20 mg, Cholecalciferol 800IU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK-R215Drug
Investigational product is prescribed to all ofrandomized subjects
Bazedoxifene 20 mgDrug
Investigational product is prescribed to all of randomized subjects
Cholecalciferol 800IUDrug
Investigational product is prescribed to all of randomized subjects
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | AK-R215, test drug Receives: Drug: AK-R215; Drug: Bazedoxifene 20 mg; Drug: Cholecalciferol 800IU |
| B group | Active comparator | reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU Receives: Drug: AK-R215; Drug: Bazedoxifene 20 mg; Drug: Cholecalciferol 800IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Cmax
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Secondary outcomes (3)
Tmax
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
AUCinf,
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
T1/2
Measured: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start13 Jul 2017
- Primary completion18 Sep 2017
- Study completion12 Jan 2018 (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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321318
- Sponsor's protocol ID
- AK-CTR-215-I-02
- Status last verified
- Oct 2017
- First submitted
- 19 Jul 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AK-R215 Pharmacokinetic Study Pharmacokinetic Characteristics of AK-R215 in Comparison to Each Component Coadministered in Healthy Adult Male or Menopausal Female Valunteers.
- ClinicalTrials.gov ID
- NCT03321318
- Acronym / sponsor ID
- AK-CTR-215-I-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 12 Jan 2018 (estimated)
- First posted
- 25 Oct 2017 (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.
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215
Detailed description
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of AK-R215 in healthy adult male or menopausal female volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: AK-R215, Drug: Bazedoxifene 20 mg, Drug: Cholecalciferol 800IUAK-R215, test drug |
| B group | Active comparator | Drug: AK-R215, Drug: Bazedoxifene 20 mg, Drug: Cholecalciferol 800IUreference drug, Bazedoxifene 20mg, Cholecalciferol 800IU |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 |
|---|---|---|
| AK-R215Investigational product is prescribed to all ofrandomized subjects | Drug | A group, B group |
| Bazedoxifene 20 mgInvestigational product is prescribed to all of randomized subjects | Drug | A group, B group |
| Cholecalciferol 800IUInvestigational product is prescribed to all of randomized subjects | Drug | A group, B group |
Primary outcome
AUC0-t
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Cmax
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
3 secondary outcomes
Tmax
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
AUCinf,
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
T1/2
Time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
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 AK-R215, Bazedoxifene 20 mg and Cholecalciferol 800IU 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 2 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 25 Oct 2017. 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?
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?
AUC0-t (time frame: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h). 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?
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 25 Oct 2017.