Bioequivalence StudyPhase 1NCT03765944
Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets
A Phase 1 study testing sirolimus in people with Bioequivalence Study, run by Nobelpharma at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study
- What is being tested?
- sirolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- 5 Dec 2018to 29 Dec 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 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy subjects aged 20 to 39 years of age
- Subjects with BMI ≥ 18.5 kg/m2 and < 25.0 kg/m2
- Subjects who are considered by the investigator as suitable for participation in the trial from lab test results at screening
- Subjects who are considered by the investigator as suitable for participation in the trial from lab test results on the day before administration
- Subjects who write informed consent
- Subjects who are able to comply with the study requirements during the study period
Who cannot join
- Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative
- Subjects who have a history of hypersensitivity or allergies to other drug
- SUbjects who have an acute or chronic infectious diseases
- Subjects who have a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments
- Subjects who have diagnosed with alcoholism or a history of alcoholism
- Subjects who have an abnormal findings (pneumonia, etc) from the result of chest CT at screening
Show all 17Show fewer
- Subjects who have been administered other investigational drug within 12 weeks before the initial administration
- Subjects who have performed blood collection or donation as follows
- Collected or donated 200 ml or more whole blood within 4 weeks before the initial administration
- Male subject; collected or donated more than 400 mL whole blood within 12 weeks before the initial administration
- Female subjects; collected or donated more than 400 mL whole blood within 16 weeks before the initial administration
- Collected or donated blood component within 2 weeks before the initial administration
- Subjects who have positive results for HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen/antibody, or syphilis
- Subjects who received any non-prescription or prescription drug within 12 weeks before the initial administration
- Subjects who are pregnant/lactating, or do not agree to contraception during the period from the screening until 8 weeks after the final administration due to planning to become pregnant
- Subjects who cannot speak, read and write in Japanese
- Subjects who are considered by the investigator as unsuitable for participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Randomized, Open-label, 2-Period, 2-way Crossover, Bioequivalence Study of Sirolimus Granules and Sirolimus Tablets in Japanese Healthy Adults
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults
- Conditions
- Bioequivalence Study
- Being tested
- sirolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimusDrug
SIngle administration under fasted condition
| Study group | Role | What they receive |
|---|---|---|
| NPC-12 granule | Active comparator | NPC-12 granules (1.0g: 2mg sirolimus) Receives: Drug: sirolimus |
| NPC-12T tablet | Active comparator | NPC-12T 2 tablets (2mg sirolimus) Receives: Drug: sirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sirolimus concentration
Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.
Measured: Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start5 Dec 2018
- Primary completion29 Dec 2018
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence StudyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765944
- Sponsor's protocol ID
- NPC-12T-1
- Status last verified
- Feb 2019
- First submitted
- 3 Dec 2018
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Open-label, 2-Period, 2-way Crossover, Bioequivalence Study of Sirolimus Granules and Sirolimus Tablets in Japanese Healthy Adults
- ClinicalTrials.gov ID
- NCT03765944
- Acronym / sponsor ID
- NPC-12T-1
- Conditions
- Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 29 Dec 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 5 Dec 2018 (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.
The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPC-12 granule | Active comparator | Drug: sirolimusNPC-12 granules (1.0g: 2mg sirolimus) |
| NPC-12T tablet | Active comparator | Drug: sirolimusNPC-12T 2 tablets (2mg sirolimus) |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Japanese healthy subjects aged 20 to 39 years of age
- Subjects with BMI ≥ 18.5 kg/m2 and < 25.0 kg/m2
- Subjects who are considered by the investigator as suitable for participation in the trial from lab test results at screening
- Subjects who are considered by the investigator as suitable for participation in the trial from lab test results on the day before administration
- Subjects who write informed consent
Key exclusion criteria (17 listed)
- Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative
- Subjects who have a history of hypersensitivity or allergies to other drug
- SUbjects who have an acute or chronic infectious diseases
- Subjects who have a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments
- Subjects who have diagnosed with alcoholism or a history of alcoholism
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 |
|---|---|---|
| sirolimusSIngle administration under fasted condition | Drug | NPC-12 granule, NPC-12T tablet |
Primary outcome
Blood sirolimus concentration
Time frame: Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)
Whole blood concentration of sirolimus will be measured and compared between NPC-12 granules and NPC-12T tablets.
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 25 Feb 2019.
- 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.
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 sirolimus in people with Bioequivalence Study, run by Nobelpharma at 1 site in Japan.
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 6 inclusion and 17 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 25 Feb 2019. 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 Japan. 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?
Blood sirolimus concentration (time frame: Pre-dose and post-dose (0.5, 1, 1.5, 2, 4, 8, 12, 18, 24, 48 and 72 hours)). 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 Feb 2019.