Pharmacokinetics in Healthy Subjects
Conditions
Brief summary
Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. There is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine. The aims of this study are to: * Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral thiamine in healthy volunteers; * Compare the different thiamine doses on the pharmacokinetic variables using repeated measures ANOVA.
Interventions
DIETARY_SUPPLEMENTThiamine
Vitamin B1
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Baystate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 55
Exclusion criteria
* Non dietary thiamine supplement within two weeks of the start of the study or during the study * History of thiamine deficiency * Anemia (Hgb\<10) * History of gastrointestinal absorption disorders * Taking prescription or over-the-counter medication * Pregnant or breast feeding a child * Alcohol and or drug abuse * Smoker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) for whole blood | predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose |
| Area Under the Curve (AUC) for plasma | predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose |
Countries
United States
Outcome results
None listed