scholarly journals Plasma Pharmacokinetic Parameters of Dexamethasone Following Administration of a Dexamethasone Intracanalicular Insert in Healthy Adults

2021 ◽  
Vol Volume 15 ◽  
pp. 2055-2061
Author(s):  
Charles Blizzard ◽  
Eugene B McLaurin ◽  
Arthur Driscoll ◽  
Fabiana Q Silva ◽  
Srilatha Vantipalli ◽  
...  
Keyword(s):  
Healthy Adults ◽  
Pharmacokinetic Parameters ◽  
Plasma Pharmacokinetic

Brain tumor accumulation and plasma pharmacokinetic parameters of 2′-deoxy-5-18F-fluorouridine

1993 ◽  
Vol 7 (3) ◽  
pp. 199-205 ◽  
Author(s):  
Kiichi Ishiwata ◽  
Yuji Tsurumi ◽  
Motonobu Kameyama ◽  
Kiyotaka Sato ◽  
Ren Iwata ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Pharmacokinetic Parameters ◽  
Tumor Accumulation ◽  
Plasma Pharmacokinetic

scholarly journals Prolonged Stimulation of Growth Hormone (GH) and Insulin-Like Growth Factor I Secretion by CJC-1295, a Long-Acting Analog of GH-Releasing Hormone, in Healthy Adults

2006 ◽  
Vol 91 (3) ◽  
pp. 799-805 ◽  
Author(s):  
Sam L. Teichman ◽  
Ann Neale ◽  
Betty Lawrence ◽  
Catherine Gagnon ◽  
Jean-Paul Castaigne ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Subcutaneous Administration ◽  
Cumulative Effect ◽  
Healthy Adults ◽  
Pharmacokinetic Parameters ◽  
Double Blind ◽  
Duration Of Action ◽  
Igf I ◽  
Long Acting ◽  
Dose Dependent

Abstract Context: Therapeutic use of GHRH to enhance GH secretion is limited by its short duration of action. Objective: The objective of this study was to examine the pharmacokinetic profile, pharmacodynamic effects, and safety of CJC-1295, a long-acting GHRH analog. Design: The study design was two randomized, placebo-controlled, double-blind, ascending dose trials with durations of 28 and 49 d. Setting: The study was performed at two investigational sites. Participants: Healthy subjects, ages 21–61 yr, were studied. Interventions: CJC-1295 or placebo was administered sc in one of four ascending single doses in the first study and in two or three weekly or biweekly doses in the second study. Main Outcome Measures: The main outcome measures were peak concentrations and area under the curve of GH and IGF-I; standard pharmacokinetic parameters were used for CJC-1295. Results: After a single injection of CJC-1295, there were dose-dependent increases in mean plasma GH concentrations by 2- to 10-fold for 6 d or more and in mean plasma IGF-I concentrations by 1.5- to 3-fold for 9–11 d. The estimated half-life of CJC-1295 was 5.8–8.1 d. After multiple CJC-1295 doses, mean IGF-I levels remained above baseline for up to 28 d. No serious adverse reactions were reported. Conclusions: Subcutaneous administration of CJC-1295 resulted in sustained, dose-dependent increases in GH and IGF-I levels in healthy adults and was safe and relatively well tolerated, particularly at doses of 30 or 60 μg/kg. There was evidence of a cumulative effect after multiple doses. These data support the potential utility of CJC-1295 as a therapeutic agent.

scholarly journals Ritonavir Increases Plasma Amprenavir (APV) Exposure to a Similar Extent when Coadministered with either Fosamprenavir or APV

2006 ◽  
Vol 50 (4) ◽  
pp. 1578-1580 ◽  
Author(s):  
Mary B. Wire ◽  
Katherine L. Baker ◽  
Lori S. Jones ◽  
Mark J. Shelton ◽  
Yu Lou ◽  
...  
Keyword(s):  
Healthy Adults ◽  
Pharmacokinetic Parameters ◽  
Similar Extent

ABSTRACT To compare the effect of ritonavir on plasma amprenavir pharmacokinetics, healthy adults received either fosamprenavir (700 mg twice a day [BID]) or amprenavir (600 mg BID) alone and in combination with ritonavir (100 mg BID). Ritonavir increased plasma amprenavir pharmacokinetic parameters to a similar extent when coadministered with either fosamprenavir or amprenavir.

scholarly journals Pharmacokinetic Parameters and Tissue Withdrawal Intervals for Sheep Administered Multiple Oral Doses of Meloxicam

Animals ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 2797
Author(s):  
Sarah Depenbrock ◽  
Tara Urbano ◽  
Jessie Ziegler ◽  
Scott Wetzlich ◽  
Maaike O. Clapham ◽  
...  
Keyword(s):  
Regulatory Agency ◽  
Multiple Dose ◽  
Pharmacokinetic Parameters ◽  
Pharmacokinetic Studies ◽  
Plasma Samples ◽  
Follow Up Study ◽  
Sample Data ◽  
Oral Doses ◽  
Plasma Pharmacokinetic

Meloxicam is an anti-inflammatory drug used to treat pain and inflammation in ruminants including sheep, and pharmacokinetic studies are needed to protect the food supply from drug residues after use in food-producing animals. This study estimated plasma pharmacokinetic parameters and meat withdrawal intervals (WDI) for market sheep after multiple daily oral doses of meloxicam. Single and multiple dose plasma pharmacokinetic studies, a multi-dose tissue depletion study, and a follow-up study to investigate if events prior to slaughter were associated with differences in plasma meloxicam concentrations, all using sample data collected after completion of dosing, were completed. Using regulatory agency methods for calculating withdrawal times, an estimated WDI of at least 10 d following the last dose is recommended for market lambs treated with 10 daily oral 1 mg/kg doses of meloxicam tablets suspended in water. The effect of events surrounding slaughter on plasma meloxicam concentrations in lambs is unknown but should be considered if plasma samples are obtained immediately prior to or during the slaughter process and used for pharmacokinetic investigations.

Safety, tolerability, pharmacokinetics, and pharmacodynamics of oral JNJ-64794964, a TLR-7 agonist, in healthy adults

2021 ◽  
pp. 135965352110565
Author(s):  
Edward Gane ◽  
Mina Pastagia ◽  
Ullrich Schwertschlag ◽  
An De Creus ◽  
Christian Schwabe ◽  
...  
Keyword(s):  
Human Study ◽  
Serum Levels ◽  
Healthy Adults ◽  
Pharmacokinetic Parameters ◽  
Interferon Α ◽  
Serious Adverse Events ◽  
Interferon Stimulated Genes ◽  
Cotton Wool Spots ◽  
Fasted State ◽  
Dose Proportional

Background This Phase I, two-part, first-in-human study assessed safety/tolerability and pharmacokinetics/pharmacodynamics of single-ascending doses (SAD) and multiple doses (MD) of the oral toll-like receptor-7 agonist, JNJ-64794964 (JNJ-4964) in healthy adults. Methods In the SAD phase, participants received JNJ-4964 0.2 ( N = 6), 0.6 ( N = 6), 1.25 ( N = 8) or 1.8 mg ( N = 6) or placebo ( N = 2/dose cohort) in a fasted state. Food effect was evaluated for the 1.25 mg cohort following ≥6 weeks washout. In the MD phase, participants received JNJ-4964 1.25 mg ( N = 6) or placebo ( N = 2) weekly (fasted) for 4 weeks. Participants were followed-up for 4 weeks. Results No serious adverse events (AEs) occurred. 10/34 (SAD) and 5/8 (MD) participants reported mild-to-moderate (≤Grade 2), transient, reversible AEs possibly related to JNJ-4964. Five (SAD) participants had fever/flu-like AEs, coinciding with interferon-α serum levels ≥100 pg/mL and lymphopenia (<1 × 109/L), between 24–48 h after dosing and resolving approximately 96 h after dosing. One participant (MD) had an asymptomatic Grade 1 AE of retinal exudates (cotton wool spots) during follow-up, resolving 6 weeks after observation. JNJ-4964 exhibited dose-proportional pharmacokinetics, with rapid absorption (tmax 0.5–0.75 h) and distribution, and a long terminal half-life (150–591 h). Overall, no significant differences in JNJ-4964 pharmacokinetic parameters were observed in the fed versus fasted state. JNJ-4964 dose-dependently and transiently induced cytokines with potential anti-HBV activity, including interferon-α, IP-10, IL-1 RA, and/or MCP-1, and interferon-stimulated genes (ISG15, MX1, and OAS1) in serum. Conclusions In healthy adults, JNJ-4964 was generally well-tolerated, exhibited dose-proportional pharmacokinetics and induced cytokines/ISGs, with possible anti-HBV activity.

Some Plasma Pharmacokinetic Parameters of Isoniazid in the Presence of a Fluoroquinolone Antibacterial Agent

2001 ◽  
Vol 8 (4) ◽  
pp. 243-246 ◽  
Author(s):  
Sabinus I. Ofoefule ◽  
Chioma E. Obodo ◽  
Orish E. Orisakwe ◽  
Ndidiamaka A. Ilondu ◽  
Onyenmechi J. Afonne ◽  
...  
Keyword(s):  
Antibacterial Agent ◽  
Pharmacokinetic Parameters ◽  
Plasma Pharmacokinetic

scholarly journals Development and Optimization of a High Sensitivity LC-MS/MS Method for the Determination of Hesperidin and Naringenin in Rat Plasma: Pharmacokinetic Approach

Molecules ◽  
2020 ◽  
Vol 25 (18) ◽  
pp. 4241
Author(s):  
Jesús Alfredo Araujo-León ◽  
Rolffy Ortiz-Andrade ◽  
Rivelino Armando Vera-Sánchez ◽  
Julio Enrique Oney-Montalvo ◽  
Tania Isolina Coral-Martínez ◽  
...  
Keyword(s):  
Multiple Reaction Monitoring ◽  
Detection Limits ◽  
High Sensitivity ◽  
Rat Plasma ◽  
Pharmacokinetic Parameters ◽  
Intragastric Administration ◽  
Validation Parameters ◽  
Plasma Pharmacokinetic ◽  
Pharmacokinetic Approach

The purpose of this study was to develop, optimize, and fully validate a high-sensitivity methodology using UHPLC-MS/MS to simultaneously quantify hesperidin and naringenin in microsamples (100 µL) of murine plasma after intragastric administration of single pure flavonoids and a mixture. The optimization process allowed for high sensitivity with detection limits of approximately picogram order using an electrospray ionization (ESI) source in negative mode and an experiment based on multiple reaction monitoring (MRM). The validation parameters showed excellent linearity and detection limits, with a precision of less than 8% and a recovery of over 90%. This methodology was applied to compare the pharmacokinetic parameters for the administration of hesperidin and naringenin in individual form or in the form of a mixture. The results showed an absence of significant effects (p > 0.05) for Tmax and Cmax; however, the AUC presented significant differences (p < 0.05) for both flavonoids when administered as a mixture, showing an improved absorption ratio for both flavonoids.

scholarly journals Levofloxacin and Ciprofloxacin Decrease Procainamide and N-Acetylprocainamide Renal Clearances

2005 ◽  
Vol 49 (4) ◽  
pp. 1649-1651 ◽  
Author(s):  
Larry A. Bauer ◽  
Douglas J. Black ◽  
Jennifer S. Lill ◽  
Julie Garrison ◽  
Vidmantas A. Raisys ◽  
...  
Keyword(s):  
Drug Interaction ◽  
Creatinine Clearance ◽  
Renal Clearance ◽  
Healthy Adults ◽  
Pharmacokinetic Parameters ◽  
Interaction Study ◽  
Drug Interaction Study ◽  
Renal Clearances

ABSTRACT Ten healthy adults participated in a randomized, crossover drug interaction study testing procainamide only, procainamide plus levofloxacin, and procainamide plus ciprofloxacin. During levofloxacin therapy, most procainamide and N-acetylprocainamide (NAPA) pharmacokinetic parameters, including decreased renal clearances and renal clearance/creatinine clearance ratios, changed (P < 0.05). During ciprofloxacin treatment, only procainamide and NAPA renal clearances decreased significantly.

scholarly journals Steady-State Pharmacokinetics of Micafungin and Voriconazole after Separate and Concomitant Dosing in Healthy Adults

2006 ◽  
Vol 51 (2) ◽  
pp. 787-790 ◽  
Author(s):  
J. Keirns ◽  
T. Sawamoto ◽  
M. Holum ◽  
D. Buell ◽  
W. Wisemandle ◽  
...  
Keyword(s):  
Drug Interaction ◽  
Steady State ◽  
Least Squares ◽  
Confidence Intervals ◽  
Healthy Adults ◽  
Pharmacokinetic Parameters

ABSTRACT We assessed the pharmacokinetics and interactions of steady-state micafungin (Mycamine) or placebo with steady-state voriconazole in 35 volunteers. The 90% confidence intervals around the least-squares mean ratios for micafungin pharmacokinetic parameters and placebo-corrected voriconazole pharmacokinetic parameters were within the 80%-to-125% limits, indicating an absence of drug interaction.

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