Healthy VolunteersPhase 4NCT07665671
Vitamin B12 Absorption Study
A Phase 4 study testing Ampli-B and Vitamin B12 in people with Healthy Volunteers, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial summary
This randomized, double-blind, crossover trial (Phase IV) aims to compare the absorption of a novel permeability-enhanced oral vitamin B12 formulation (Ampli-B) versus standard oral vitamin B12 in 12 healthy adults aged 50 years and older. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ampli-B and Vitamin B12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Jul 2026to 21 Aug 2026
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 50 years of age and older
- BMI between 18 to 29.9 kg/m2
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- Woman of child-bearing potential (WOCBP) must be following appropriate contraceptive methods until the last visit:
- Sexual abstinence.
- Oral contraceptive.
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- Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration).
- Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration).
- Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- Contraceptives must be effective before product administration.
- Agrees not to take any vitamin B12 containing supplements until the completion of the study.
- Agrees to avoid consuming liver, kidney, organ meats and very high B12 containing shellfish (e.g. clams and crab) 72 hours prior to study visits
- Agrees to consume the standardized meals for each of the study visits
- Agrees to avoid alcohol intake 48 hours prior to study visits
- Agrees to maintain current lifestyle habits (physical activity, medications, supplements, and sleep) as much as possible throughout the study
- Able to fast for 10 hours prior to study visits (visit 1 and visit 3)
- Provided voluntary, written, informed consent to participate in the study
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products
- History or current diagnosis of any clinically significant disease that may alter vitamin B12 absorption, accumulation, metabolism or excretion
- Taking vitamin B12 supplements or a multivitamin supplement containing vitamin B12 within the prior 2 months from study product administration.
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the absorption of vitamin B12
- Have a serious illness e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, diabetes, liver disease, autoimmune disease, bleeding disorders or heart conditions
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- Have an unstable illness e.g. diabetes and thyroid gland dysfunction
- Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
- Gastrointestinal or absorption issues (IBD, IBS, Celiac disease, Crohn's disease, history of GI surgery, Small Intestinal Bacterial Overgrowth)
- Poor venous access
- Current use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- Active smokers, nicotine use or drug (prescription or illegal substances) abuse.
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Blood donation 60 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the PI
- Any other condition or lifestyle factor, that, in the opinion of the PI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Cross-Over Clinical Trial to Compare the Absorption of Different Forms of Vitamin B12 (AMPLIB12)
This randomized, double-blind, crossover trial (Phase IV) aims to compare the absorption of a novel permeability-enhanced oral vitamin B12 formulation (Ampli-B) versus standard oral vitamin B12 in 12 healthy adults aged 50 years and older. Each participant receives a single dose of each formulation in randomized sequence, separated by a minimum 10-day washout. The primary outcome is time to peak serum concentration (Tmax) of total and active vitamin B12 (holotranscobalamin). Secondary outcomes include Cmax and AUC parameters.
- Conditions
- Healthy Volunteers
- Being tested
- Ampli-B, Vitamin B12
- Keywords
- 50 years and older
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ampli-BDietary supplement
Also called Vitamin B12
Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.
Vitamin B12Dietary supplement
Also called cobalamin
Participants will receive a single capsule containing 1mg vitamin B12 .
| Study group | Role | What they receive |
|---|---|---|
| Ampli-B | Experimental | Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer. Receives: Dietary Supplement: Ampli-B |
| Standard B12 | Active comparator | Participants will receive a single capsule containing 1mg vitamin B12. Receives: Dietary Supplement: Vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12.
Comparison of the time to peak maximum concentration (tmax) of total serum cyanocobalamin (total vitamin B12) and active cyanocobalamin [holotranscobalamin (holoTC)] between AmpliB and standard vitamin B12.
Measured: Day 1 to 24hrs post Visit 3 (visit 4/day 11)
Secondary outcomes (10)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 Cmax
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
- The maximum concentration (Cmax)
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 area under the concentration-time curve from 0h to 24hr
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
- The area under the concentration-time curve from 0 h to time of last measured concentration (AUC0-24h)
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 area under the concentration-time curve from 0 h to infinity
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
- The area under the concentration-time curve from 0 h to infinity (AUC0-∞)
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal disposition rate constant
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
- The terminal disposition rate constant (λ)
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal half-life
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
- The terminal half-life (t½)
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin Cmax
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters:
- Cmax
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin area under the concentration-time curve from 0 h to 24h
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters:
- The area under the concentration-time curve from 0 h to time of last measured concentration (AUC0-24h)
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin area under the concentration-time curve from 0 h to infinity
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters:
- The area under the concentration-time curve from 0 h to infinity (AUC0-∞)
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin terminal disposition rate constant
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters:
- The terminal disposition rate constant (λ)
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin terminal half-life
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters:
- The terminal half-life (t½)
Measured: Baseline to 24hours post visit 3 (visit 4/day 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start20 Jul 2026
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
- Investigators
- Alexandros Kanellopoulos, Study director, dsm-firmenich Switzerland AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665671
- Sponsor's protocol ID
- 2024-06-28-AMPLIB
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Cross-Over Clinical Trial to Compare the Absorption of Different Forms of Vitamin B12 (AMPLIB12)
- ClinicalTrials.gov ID
- NCT07665671
- Acronym / sponsor ID
- 2024-06-28-AMPLIB
- Conditions
- Healthy Volunteers
- Keywords
- 50 years and older
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 21 Aug 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 24 Jun 2026 (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.
This randomized, double-blind, crossover trial (Phase IV) aims to compare the absorption of a novel permeability-enhanced oral vitamin B12 formulation (Ampli-B) versus standard oral vitamin B12 in 12 healthy adults aged 50 years and older. Each participant receives a single dose of each formulation in randomized sequence, separated by a minimum 10-day washout. The primary outcome is time to peak serum concentration (Tmax) of total and active vitamin B12 (holotranscobalamin). Secondary outcomes include Cmax and AUC parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ampli-B | Experimental | Dietary Supplement: Ampli-BParticipants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer. |
| Standard B12 | Active comparator | Dietary Supplement: Vitamin B12Participants will receive a single capsule containing 1mg vitamin B12. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males and females 50 years of age and older
- BMI between 18 to 29.9 kg/m2
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- Woman of child-bearing potential (WOCBP) must be following appropriate contraceptive methods until the last visit:
- Agrees not to take any vitamin B12 containing supplements until the completion of the study.
Key exclusion criteria (16 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products
- History or current diagnosis of any clinically significant disease that may alter vitamin B12 absorption, accumulation, metabolism or excretion
- Taking vitamin B12 supplements or a multivitamin supplement containing vitamin B12 within the prior 2 months from study product administration.
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the absorption of vitamin B12
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 |
|---|---|---|
| Ampli-BAlso: Vitamin B12Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer. | Dietary supplement | Ampli-B |
| Vitamin B12Also: cobalaminParticipants will receive a single capsule containing 1mg vitamin B12 . | Dietary supplement | Standard B12 |
Primary outcome
Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12.
Time frame: Day 1 to 24hrs post Visit 3 (visit 4/day 11)
Comparison of the time to peak maximum concentration (tmax) of total serum cyanocobalamin (total vitamin B12) and active cyanocobalamin [holotranscobalamin (holoTC)] between AmpliB and standard vitamin B12.
10 secondary outcomes
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 Cmax
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 area under the concentration-time curve from 0h to 24hr
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 area under the concentration-time curve from 0 h to infinity
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal disposition rate constant
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal half-life
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin Cmax
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin area under the concentration-time curve from 0 h to 24h
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin area under the concentration-time curve from 0 h to infinity
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin terminal disposition rate constant
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin terminal half-life
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
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 9 Sep 2026.
- 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.
Alexandros Kanellopoulos study director
dsm-firmenich Switzerland AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ampli-B and Vitamin B12 in people with Healthy Volunteers, run by RDC Clinical Pty Ltd at 1 site in Australia.
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 17 inclusion and 16 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 9 Sep 2026. 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 Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12. (time frame: Day 1 to 24hrs post Visit 3 (visit 4/day 11)). 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 9 Sep 2026.