Tier 2 — strong

The use of betaine HCl to enhance dasatinib absorption in healthy volunteers with rabeprazole-induced hypochlorhydria

Marc R Yago, Adam Frymoyer, Leslie Z Benet, Gillian S Smelick, Lynda A Frassetto, Xiao Ding, Brian Dean, Laurent Salphati, Nageshwar Budha, Jin Y Jin, Mark J Dresser, Joseph A Ware
The AAPS journal 2014 16(6):1358-1365

Bibliography

PubMed
PMID 25274610
PubMed Central
PMC4389759
DOI
10.1208/s12248-014-9673-9
Funding
Indexed grant support: T32 GM007175 — NIGMS NIH HHS — United States; UL1 RR0224131 — NCRR NIH HHS — United States. The indexed list may not contain the complete funding declaration.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignRandomized crossover controlled trial
ModelHuman participants
SampleHealthy volunteers in a three-period pharmacokinetic study
InterventionDasatinib 100 mg with or without rabeprazole and betaine HCl 1.5 g
DurationSingle-dose pharmacokinetic periods
EndpointsDasatinib exposure; Drug-acid interaction

What the study showed, in plain terms

Published in 2014, this source examined betaine hcl and topical formulations. Design: Randomized crossover controlled trial. Sample/model: Healthy volunteers in a three-period pharmacokinetic study. The exposure or intervention was Dasatinib 100 mg with or without rabeprazole and betaine HCl 1.5 g. Follow-up or treatment period: Single-dose pharmacokinetic periods.

Betaine HCl reversed much of the reduction in dasatinib exposure caused by rabeprazole under the tested conditions.

A drug-absorption experiment in healthy volunteers, not a cancer-outcome trial. Prescription-drug combinations require clinical management.

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Key findings

  • Betaine HCl reversed much of the reduction in dasatinib exposure caused by rabeprazole under the tested conditions.
  • The recorded outcome domains were Dasatinib exposure; Drug-acid interaction.
  • The result applies to the tested exposure: Dasatinib 100 mg with or without rabeprazole and betaine HCl 1.5 g; Single-dose pharmacokinetic periods.

What this study can and cannot tell us

  • A drug-absorption experiment in healthy volunteers, not a cancer-outcome trial. Prescription-drug combinations require clinical management.
  • An individual controlled trial must be interpreted alongside its comparator, sample size, endpoint selection and independent replication. It does not validate a different commercial formulation or a general longevity claim.
  • Source basis: Indexed abstract and bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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Gastric reacidification with betaine HCl in healthy volunteers with rabeprazole-induced hypochlorhydria
Marc R Yago et al. · Molecular pharmaceutics · 2013
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Food, Acid Supplementation and Drug Absorption - a Complicated Gastric Mix: a Randomized Control Trial
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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology