Focus: BioavailabilityPhase 1NCT01306123
Characterization of Cyanocobalamin in Healthy Voluteers After Intranasal and Intramuscual Administration
A Phase 1 study testing Nascobal nasal spray (cyanocobalamin, USP) and Vitamin B12-ratiopharm N, injection solution in people with Focus: Bioavailability, run by Swedish Orphan Biovitrum at 1 site in Sweden.
Trial summary
The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal Spray as compared to an IM injection of cyanocobalamin (European reference product). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus: Bioavailability
- What is being tested?
- Nascobal nasal spray (cyanocobalamin, USP) and Vitamin B12-ratiopharm N, injection solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2011to May 2011
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female and male voluteers
- 18-40 years of age
- BMI between 18.5 and 30.0 kg/m2
Who cannot join
- Females who are pregnant or lactating
- History of clinically significant metabolic, hepatic, renal, haematological, pulmondary, cardiovascular, gastrointestinal, urological, neurological or phychiatric disorders
- Serum vitamin B12 <=250 pmol/L or MMA >=0.40 umol/L
- Evidence of significant intranasal pathology
- Nasal congestion, allergic rhinitis or upper respiratory tract infection
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Trial Alliance, Karolinska University Hospital, Huddinge
Stockholm, Stockholm County, 141 86
About this study
Official title: An Open, Randomized, Single-dose, Two-way Crossover Study to Characterize the Pharmacokinetic Properties of Cyanocobalamin When Administered as an Intranasal Spray and an Intramuscular Injection to Healthy Volunteers
The main purpose of this study is to assess the relative bioavailability of Nascobal Nasal Spray as compared to an IM injection of cyanocobalamin (European reference product).
Read the detailed description
This is an open-label, randomized, single-dose, two-way crossover study. The study consists of a screening visit, two 4-days confinement periods and a follow-up telephone call. The two confinement periods will be separated by a washout period of at least 28 days.
- Conditions
- Focus: Bioavailability
- Being tested
- Nascobal nasal spray (cyanocobalamin, USP), Vitamin B12-ratiopharm N, injection solution
- Keywords
- bioavailability, pharmacokinetics, cyanocobalamin, intranasal, intramuscular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nascobal nasal spray (cyanocobalamin, USP)Drug
Single intranasal administration
Vitamin B12-ratiopharm N, injection solutionDrug
One single intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| Nascobal nasal spray (cyanocobalamin USP) | Experimental | One single administration of intranasal cyanocobalamin (initially) Receives: Drug: Nascobal nasal spray (cyanocobalamin, USP) |
| Vitamin B12-ratiopharm N, injection solution | Active comparator | One single injection of IM cyanocobalamin (initially) Receives: Drug: Vitamin B12-ratiopharm N, injection solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability
Relative bioavailability (Frel) based on the area under the serum concentration-time curve during 72 hours (AUC0-72h) for the test and reference products.
Measured: 0-72 hours
Secondary outcomes (1)
Additional PK characteristics
Maximum serum concentration (Cmax), time of Cmax (tmax) and AUC0-24h.
Measured: 0-72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: BioavailabilityStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nabil Al-Tawil, MD, PhD, Principal investigator, Karolinska Trial Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306123
- Sponsor's protocol ID
- NSB09/17
- Status last verified
- Oct 2014
- First submitted
- 28 Feb 2011
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Single-dose, Two-way Crossover Study to Characterize the Pharmacokinetic Properties of Cyanocobalamin When Administered as an Intranasal Spray and an Intramuscular Injection to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01306123
- Acronym / sponsor ID
- NSB09/17
- Conditions
- Focus: Bioavailability
- Keywords
- bioavailability, pharmacokinetics, cyanocobalamin, intranasal, intramuscular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Mar 2011 (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 main purpose of this study is to assess the relative bioavailability of Nascobal Nasal Spray as compared to an IM injection of cyanocobalamin (European reference product).
Detailed description
This is an open-label, randomized, single-dose, two-way crossover study. The study consists of a screening visit, two 4-days confinement periods and a follow-up telephone call. The two confinement periods will be separated by a washout period of at least 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nascobal nasal spray (cyanocobalamin USP) | Experimental | Drug: Nascobal nasal spray (cyanocobalamin, USP)One single administration of intranasal cyanocobalamin (initially) |
| Vitamin B12-ratiopharm N, injection solution | Active comparator | Drug: Vitamin B12-ratiopharm N, injection solutionOne single injection of IM cyanocobalamin (initially) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy female and male voluteers
- 18-40 years of age
- BMI between 18.5 and 30.0 kg/m2
Key exclusion criteria (5 listed)
- Females who are pregnant or lactating
- History of clinically significant metabolic, hepatic, renal, haematological, pulmondary, cardiovascular, gastrointestinal, urological, neurological or phychiatric disorders
- Serum vitamin B12 <=250 pmol/L or MMA >=0.40 umol/L
- Evidence of significant intranasal pathology
- Nasal congestion, allergic rhinitis or upper respiratory tract infection
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 |
|---|---|---|
| Nascobal nasal spray (cyanocobalamin, USP)Single intranasal administration | Drug | Nascobal nasal spray (cyanocobalamin USP) |
| Vitamin B12-ratiopharm N, injection solutionOne single intramuscular administration | Drug | Vitamin B12-ratiopharm N, injection solution |
Primary outcome
Relative bioavailability
Time frame: 0-72 hours
Relative bioavailability (Frel) based on the area under the serum concentration-time curve during 72 hours (AUC0-72h) for the test and reference products.
1 secondary outcome
Additional PK characteristics
Time frame: 0-72h
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 3 Nov 2014.
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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.
Nabil Al-Tawil, MD, PhD principal investigator
Karolinska Trial Alliance
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 Nascobal nasal spray (cyanocobalamin, USP) and Vitamin B12-ratiopharm N, injection solution in people with Focus: Bioavailability, run by Swedish Orphan Biovitrum at 1 site in Sweden.
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 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 3 Nov 2014. 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 Sweden. 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?
Relative bioavailability (time frame: 0-72 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 3 Nov 2014.