Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| dsm-firmenich Switzerland AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ampli-B | Experimental | Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer. |
|
| Standard B12 | Active Comparator | Participants will receive a single capsule containing 1mg vitamin B12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampli-B | Dietary Supplement | Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to 24hrs post Visit 3 (visit 4/day 11) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline to 24hours post visit 3 (visit 4/day 11) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Baseline to 24hours post visit 3 (visit 4/day 11) |
| Safety: Changes in vital signs (blood pressure) |
Inclusion Criteria:
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.
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
Provided voluntary, written, informed consent to participate in the study
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Briskey | Contact | +61(0)731024486 | research@rdcglobal.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Alexandros Kanellopoulos | dsm-firmenich Switzerland AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Brisbane | Queensland | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vitamin B12 | Dietary Supplement | Participants will receive a single capsule containing 1mg vitamin B12 . |
|
|
| 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) |
| 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-∞) | 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) | 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) | 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 | 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) | 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-∞) | 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) | 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) | Baseline to 24hours post visit 3 (visit 4/day 11) |
Clinically relevant changes in vital signs blood pressure (BP) after acute supplementation
| Baseline to 24hours post visit 3 (visit 4/day 11) |
| Safety: Changes in vital signs (heart rate) | Clinically relevant changes in vital signs heart rate after acute supplementation | Baseline to 24hours post visit 3 (visit 4/day 11) |
| Safety: Changes in FBC | Clinically relevant changes in FBC after supplementation. | Baseline to 24hours post visit 3 (visit 4/day 11) |
| Safety: Changes in E/LFT | Clinically relevant changes in E/LFT after supplementation. | Baseline to 24hours post visit 3 (visit 4/day 11) |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |