RDC Clinical
Brisbane, Queensland, Australia
Location status: Recruiting
NCT Number: NCT07665671
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Phase 4
Brisbane, Queensland, Australia
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Woman of child-bearing potential (WOCBP) must be following appropriate contraceptive methods until the last visit:
Exclusion criteria
Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.
Other names: Vitamin B12
Participants will receive a single capsule containing 1mg vitamin B12 .
Other names: cobalamin
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.
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Comparison of the absorption of the total vitamin B12 formulations by evaluating the following serum vitamin B12 absorption parameters:
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 pharmacokinetic parameters:
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 pharmacokinetic parameters:
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 pharmacokinetic parameters:
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 pharmacokinetic parameters:
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 pharmacokinetic parameters:
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Incidence of post-emergent adverse events (AE)
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Clinically relevant changes in vital signs blood pressure (BP) after acute supplementation
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Clinically relevant changes in vital signs heart rate after acute supplementation
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Clinically relevant changes in FBC after supplementation.
Time frame: Baseline to 24hours post visit 3 (visit 4/day 11)
Clinically relevant changes in E/LFT after supplementation.
Contact information is provided by the study sponsor or research team.
RDC Clinical Pty Ltd
Industry
A Randomized, Double-Blind, Cross-Over Clinical Trial to Compare the Absorption of Different Forms of Vitamin B12 (AMPLIB12)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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