Influence of Enteral Feedings on Phenytoin Sodium Absorption from Capsules

1988 ◽  
Vol 22 (2) ◽  
pp. 130-133 ◽  
Author(s):  
Lyn Y. Nishimura ◽  
Edward P. Armstrong ◽  
Patricia M. Plezia ◽  
Robert P. Iacono
Keyword(s):  
Single Dose ◽  
Healthy Adult ◽  
Relative Bioavailability ◽  
Sodium Absorption ◽  
Crossover Fashion ◽  
Phenytoin Sodium ◽  
Enteral Feedings ◽  
Blood Specimens ◽  
Two Phases ◽  
Adult Volunteers

The influence of enteral feedings (with Ensure) on the absorption of phenytoin sodium from capsules was studied. Six healthy adult volunteers were given a single dose of phenytoin capsules 400 mg po on two occasions. Blood specimens were collected for 48 hours after each dose. In a randomized, crossover fashion, each subject completed the following two phases: (1) phenytoin without enteral feedings, and (2) concomitant enteral feedings before phenytoin and continued at 100 ml/h for ten hours. The areas under the concentration versus time curves from 0-48 hours (AUCo-48) were not significantly different between the two phases (p > 0.5). The percent relative bioavailability of phenytoin with enteral feedings was 101.7 percent. This study suggests that enteral feedings do not affect the serum concentrations of phenytoin after a single dose given in capsule form.

The Single-Dose Pharmacokinetics of Clopidogrel in Healthy Adult Volunteers

2003 ◽  
Vol 73 (2) ◽  
pp. P47-P47
Author(s):  
J. Grenier ◽  
S. Ciric ◽  
J. Curry ◽  
G. Morelli ◽  
A. Arseneault ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Adult ◽  
Adult Volunteers

scholarly journals Pharmacokinetics of Oral Formulations of Gepotidacin (GSK2140944), a Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor, in Healthy Adult and Adolescent Participants

2021 ◽  
Author(s):  
Aline Barth ◽  
Mohammad Hossain ◽  
Darin B. Brimhall ◽  
Caroline R. Perry ◽  
Courtney A. Tiffany ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Adult ◽  
Relative Bioavailability ◽  
Wet Granulation ◽  
Free Base ◽  
Formulation Development ◽  
Confidence Bounds ◽  
Time Curve ◽  
Bioavailability Study ◽  
New Treatment

Gepotidacin is a novel, first-in-class triazaacenaphthylene antibiotic that may provide a new treatment option for antibiotic-resistant pathogens. Two pharmacokinetic evaluations of oral gepotidacin are presented; a relative bioavailability study that guided formulation development, followed by an adult and adolescent study of the final formulation. In the relative bioavailability study, after gepotidacin administration to 26 healthy adults as free base roller compacted (RC) tablets, free base high shear wet granulation (HSWG) tablets, and mesylate salt reference capsules, the RC tablet exposure ratios and 90% confidence intervals (CIs) were within the 0.80 to 1.25 confidence bounds; however, the HSWG tablet maximum observed concentration (C max ) was higher compared to the reference (ratio: 1.15; 90% CIs: 1.0113, 1.3047). In the healthy adult (n=16) and adolescent (n=17) study, a gepotidacin mesylate salt tablet was evaluated as a 1,500-mg single dose, 2 doses administered 6 or 12 h apart (6,000 mg total), or placebo. Single-dose mean C max was ∼27% higher in adolescents versus adults and area under the concentration-time curve (AUC) was comparable in both populations. After 2 doses were administered, mean C max was similar for both ages and mean AUC was ∼35% higher in adolescents versus adults. Concentrations increased proportionally with dose. Safety-risk profiles were similar in both ages. Across studies, the most common adverse events were gastrointestinal. Overall, the pharmacokinetics of the final gepotidacin mesylate salt tablet have been well-characterized, enrollment of adolescents into the pivotal trials is supported, and dosing intervals were determined that should provide adequate exposures for microbiological efficacy.

Pharmacokinetic properties of fentanyl effervescent buccal tablets: A phase I, open-label, crossover study of single-dose 100, 200, 400, and 800 μg in healthy adult volunteers

2006 ◽  
Vol 28 (5) ◽  
pp. 707-714 ◽  
Author(s):  
Mona Darwish ◽  
Mary Kirby ◽  
Philmore Robertson ◽  
William Tracewell ◽  
John G. Jiang
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Crossover Study ◽  
Healthy Adult ◽  
Open Label ◽  
Pharmacokinetic Properties ◽  
Buccal Tablets ◽  
Adult Volunteers

Evaluation of toxicity and single-dose pharmacokinetics of intravenous ursolic acid liposomes in healthy adult volunteers and patients with advanced solid tumors

2012 ◽  
Vol 9 (2) ◽  
pp. 117-125 ◽  
Author(s):  
Xian-Huo Wang ◽  
Shi-Yong Zhou ◽  
Zheng-Zi Qian ◽  
Hui-Lai Zhang ◽  
Li-Hua Qiu ◽  
...  
Keyword(s):  
Single Dose ◽  
Solid Tumors ◽  
Ursolic Acid ◽  
Healthy Adult ◽  
Advanced Solid Tumors ◽  
Adult Volunteers
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