- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07665671
Vitamin B12 Absorption Study
A Randomized, Double-Blind, Cross-Over Clinical Trial to Compare the Absorption of Different Forms of Vitamin B12 (AMPLIB12)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: David Briskey
- Telefonní číslo: +61(0)731024486
- E-mail: research@rdcglobal.com.au
Studijní místa
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Queensland
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Brisbane, Queensland, Austrálie
- RDC Clinical
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Vrchní vyšetřovatel:
- David Briskey, PhD
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Kontakt:
- David Briskey
- Telefonní číslo: +61 (0) 731024486
- E-mail: research@rdcglobal.com.au
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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:
- Sexual abstinence.
- Oral contraceptive.
- 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
- Provided voluntary, written, informed consent to participate in the study
Exclusion Criteria:
- 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
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Ampli-B
Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.
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Participants will receive a single capsule containing 1mg vitamin B12 with a permeability enhancer.
Ostatní jména:
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Aktivní komparátor: Standard B12
Participants will receive a single capsule containing 1mg vitamin B12.
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Participants will receive a single capsule containing 1mg vitamin B12 .
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Tmax of total vitamin b12 and holoTC between AmpliB and standard vitamin B12.
Časové okno: Day 1 to 24hrs post Visit 3 (visit 4/day 11)
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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.
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Day 1 to 24hrs post Visit 3 (visit 4/day 11)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 Cmax
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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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)
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Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 area under the concentration-time curve from 0h to 24hr
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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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)
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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
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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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)
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Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal disposition rate constant
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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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)
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Comparison of the absorption of the total vitamin B12 formulations by evaluating serum B12 terminal half-life
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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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)
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Comparison of the absorption of the total vitamin B12 formulations by evaluating serum active cyanocobalamin Cmax
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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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)
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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
Časové okno: 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: • 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
Časové okno: 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: • 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
Časové okno: 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: • 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
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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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)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Safety: Incidence of post-emergent adverse events (AE)
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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Incidence of post-emergent adverse events (AE)
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Baseline to 24hours post visit 3 (visit 4/day 11)
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Safety: Changes in vital signs (blood pressure)
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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Clinically relevant changes in vital signs blood pressure (BP) after acute supplementation
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Baseline to 24hours post visit 3 (visit 4/day 11)
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Safety: Changes in vital signs (heart rate)
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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Clinically relevant changes in vital signs heart rate after acute supplementation
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Baseline to 24hours post visit 3 (visit 4/day 11)
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Safety: Changes in FBC
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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Clinically relevant changes in FBC after supplementation.
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Baseline to 24hours post visit 3 (visit 4/day 11)
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Safety: Changes in E/LFT
Časové okno: Baseline to 24hours post visit 3 (visit 4/day 11)
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Clinically relevant changes in E/LFT after supplementation.
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Baseline to 24hours post visit 3 (visit 4/day 11)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Alexandros Kanellopoulos, dsm-firmenich Switzerland AG
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Informace o lécích a zařízeních, studijní dokumenty
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