Multiple dose pharmacokinetics of caffeine administered in chewing gum to normal healthy volunteers
Syed SA, Kamimori GH, Kelly W, Eddington ND
Biopharmaceutics & drug disposition · 36 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- U.S. Army Medical Research and Development Command
Según 1 financiador declarado.
Publicación
- Publicado
- 2005-09-13 · Biopharm Drug Dispos · vol. 26 · número 9 · págs. 403–409
- Editorial
- Wiley
- Citado
- 57 citas · más que el 87% de estudios similares · 2.1× el promedio de su campo
- Referencias
- 14 trabajos
- Acceso
- De pago
- Áreas de investigación
- Coffee research and impacts · Pharmacogenetics and Drug Metabolism · Sleep and Work-Related Fatigue
- Palabras clave
- caffeine, chewing gum, pharmacokinetics, repeated dosing, dose proportionality, alertness, sleep deprivation
- MeSH
- mouth mucosa, humans, caffeine, central nervous system stimulants, metabolic clearance rate, area under curve, double-blind method, absorption, dose-response relationship, drug, chewing gum, adolescent, adult, female, male
4 autores
- Safiuddin Shoeb Syed🇺🇸University of Maryland, Baltimore
- Gary H. Kamimori🇺🇸Walter Reed Army Institute of Research
- William F. Kelly🇺🇸Walter Reed Army Institute of Research
- Natalie D. Eddington🇺🇸 · autor de correspondenciaUniversity of Maryland, Baltimore
Resumen
El texto original del estudio, en el idioma en que se publicó.
Unlabelled
The purpose of this study was to examine the pharmacokinetics of three doses of caffeine administered as Stay Alert chewing gum in a multiple dose regimen.
Methods
A double-blind, parallel randomized, four-treatment study design was employed. The treatment groups were: 50, 100 and 200 mg caffeine and placebo. Subjects were 48 (n = 12 per group), healthy, non-smoking, males and females who had abstained from caffeine ingestion for at least 20 h prior to dosing, who were randomly assigned to the treatment groups. Caffeine was administered at 2,400, 0200 and 0400 h depending on the treatment group. Blood samples were collected pre-dose and at 5, 15, 30, 45, 60, 75, 90 and 105 min after each caffeine dose. Samples were also collected at 7.5, 8.5 and 18 h after the last dose of caffeine. Plasma caffeine levels were analysed by a validated UV-HPLC method.
Result
The mean T(max) after the third dosing ranged from 0.37 to 1.12 h. C(max) for 50, 100 and 200 mg was 2.69, 3.45 and 6.33 mg/l, respectively. AUC(inf) for 50, 100 and 200 mg group was 33.2, 46.94 and 86.94 mg/l * h, respectively. AUC(inf) values suggested a dose proportionate increase. Dose normalized C(max) and AUC(0-tau) values across doses were not significantly different, suggesting linearity was maintained after multiple doses of the Stay Alert chewing gum. There were no group related differences in elimination.
Conclusions
The results suggest that caffeine administered in the gum formulation (Stay Alert chewing gum) via a multiple dosing regimen provides an effective and convenient means of maintaining effective concentrations of caffeine that would in some operational scenarios be desirable for maintaining alertness and performance in sleep deprived individuals.
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