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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.
Participants will receive a single capsule containing 1mg vitamin B12 .
RDC Clinical
Brisbane, Queensland, Australia
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.
Time frame: Day 1 to 24hrs post Visit 3 (visit 4/day 11)
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)
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
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)
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
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-∞)
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
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)
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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
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters: • The terminal half-life (t½)
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
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters: • 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
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)
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
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-∞)
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
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters: • The terminal disposition rate constant (λ)
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
Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin pharmacokinetic parameters: • The terminal half-life (t½)
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)