scholarly journals Bioequivalence Study of Modified-Release Gliclazide Tablets in Healthy Volunteers

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Noppamas Rojanasthien ◽  
Thatree Autsavakitipong ◽  
Boonyium Kumsorn ◽  
Maleeya Manorot ◽  
Supanimit Teekachunhatean
Keyword(s):  
Confidence Intervals ◽  
Plasma Concentrations ◽  
Bioequivalence Study ◽  
Modified Release ◽  
Uv Detector ◽  
Test Product ◽  
Drug Plasma Concentrations ◽  
Drug Plasma ◽  
Significant Difference ◽  
Effect Of Food

This study was aimed to investigate bioequivalence of modified-release 30 mg gliclazide tablets in 18 healthy Thai volunteers. A test product, Glycon MR (Siam Bheasach, TH), was compared with a reference product, Diamicron MR (Servier, France). The study was performed under a single-dose, two-treatment, two-period, and two-sequence crossover design in fasted and fed conditions with a washout period of 2 weeks. Blood samples were collected for 72 h after drug administration. Drug plasma concentrations were determined by HPLC with a UV detector. Analysis of pharmacokinetic characteristics was based on a non-compartmental model. The logarithmically transformed data of Cmax and AUCs were analyzed for 90% confidence intervals using ANOVA. The test product gave slightly higher Cmax in both conditions and shorter Tmax in the fed condition. However, there is no significant difference in pharmacokinetic characteristics between both products under fasted and fed conditions. Effect of food was not significantly observed. The 90% confidence intervals were within the acceptance criteria of 0.80–1.25 regardless of the food effect, indicating bioequivalence between the two products on the rate and extent of gliclazide MR absorption without regard to meals.

Antiarrhythmic Drug Plasma Concentrations in Ambulatory Patients

1996 ◽  
Vol 30 (3) ◽  
pp. 298-300 ◽  
Author(s):  
Roberto Latini ◽  
Gianna Magnolfi ◽  
Rossella Zordan ◽  
Mariano Ferrari ◽  
Roberto Padrini ◽  
...  
Keyword(s):  
Antiarrhythmic Drug ◽  
Plasma Concentrations ◽  
Drug Plasma Concentrations ◽  
Drug Plasma ◽  
Ambulatory Patients

Concentration-response relationships for three nonsteroidal anti-inflammatory drugs in the rat intestine

1995 ◽  
Vol 14 (7) ◽  
pp. 573-579 ◽  
Author(s):  
J. Ford ◽  
JB Houston
Keyword(s):  
Rank Order ◽  
Plasma Concentrations ◽  
Intestinal Damage ◽  
Rat Intestine ◽  
Response Data ◽  
Drug Plasma Concentrations ◽  
Drug Plasma ◽  
Constant Rate ◽  
Inflammatory Drugs ◽  
Intestinal Permeation

1. The effect of diclofenac, piroxicam and (S+)-ibuprofen upon the rat intestine has been measured at constant drug plasma concentrations in the rat, using (51Cr)-EDTA intestinal permeation as a measure of damage. Initially disposition studies after sc administration of the three NSAIDs were carried out. From these studies it was found that constant-rate iv infusions were necessary to maintain plasma concentrations of diclofenac and (S+)-ibuprofen. Administration of piroxicam by sc bolus gave relatively constant plasma concentrations, thus iv infusions were not necessary to obtain concentration-response data for this drug. Relative potency was found by comparing the con centration-response profiles of the three NSAIDs and the rank order of potency obtained was: diclofenac > piroxi cam > (S+)-ibuprofen. 2. The effect of mode of administration upon intestinal damage was also investigated using diclofenac. Intestinal permeability was measured in rats given diclofenac either by sc bolus or iv infusion and dose-response data com pared. It was found that for the same dose, administration by sc bolus gave a higher degree of damage than by iv infusion.

scholarly journals Analgesic efficacy and associated plasma concentration of tramadol and O-desmethyltramadol following oral administration post ovariohysterectomy in dogs

2015 ◽  
Author(s):  
Elizabeth M Goudie-DeAngelis ◽  
Kerry J Woodhouse
Keyword(s):  
Plasma Concentration ◽  
Postoperative Pain ◽  
Pain Score ◽  
Short Form ◽  
Plasma Concentrations ◽  
Analgesic Efficacy ◽  
Pain Scale ◽  
Clinical Pain ◽  
Drug Plasma ◽  
Significant Difference

Tramadol is used in both human and veterinary medicine to treat postoperative pain. The purpose of this study was to evaluate tramadol as a sole postoperative analgesic and to compare drug plasma concentration to clinical pain score. A high or low dose of tramadol was randomly assigned and administered to 14 mixed breed female dogs after ovariohysterectomy. The Short-Form of the Glasgow Composite Measure Pain Scale was used for pain evaluation post-operatively. Plasma was collected for evaluation of tramadol and O-desmethyltramadol concentrations. The effect of weight and dose on pain scores as well as how pain score correlated with plasma concentration of tramadol and O-desmethyltramadol was evaluated. A significant difference in pain score was noted between doses when weight classes were pooled. The plasma concentrations did not correlate with pain score. Based on our results, the use of tramadol as a sole analgesic agent provides inadequate postoperative pain control.

Relationship Between Antiretroviral Drug Plasma Concentrations and Viral Load in Children

2003 ◽  
Vol 32 (1) ◽  
pp. 112-115 ◽  
Author(s):  
J. M. Treluyer ◽  
M. Burgard ◽  
N. Cazali ◽  
P. Quartier ◽  
F. Veber ◽  
...  
Keyword(s):  
Viral Load ◽  
Plasma Concentrations ◽  
Drug Plasma Concentrations ◽  
Drug Plasma ◽  
Antiretroviral Drug

scholarly journals Neural correlates of the DMT experience assessed with multivariate EEG

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Christopher Timmermann ◽  
Leor Roseman ◽  
Michael Schartner ◽  
Raphael Milliere ◽  
Luke T. J. Williams ◽  
...  
Keyword(s):  
Subjective Experience ◽  
Brain Activity ◽  
Plasma Concentrations ◽  
Oscillatory Activity ◽  
Visual Component ◽  
Eyes Closed ◽  
Drug Plasma Concentrations ◽  
Drug Plasma ◽  
Oscillatory Power ◽  
Signal Diversity

AbstractStudying transitions in and out of the altered state of consciousness caused by intravenous (IV) N,N-Dimethyltryptamine (DMT - a fast-acting tryptamine psychedelic) offers a safe and powerful means of advancing knowledge on the neurobiology of conscious states. Here we sought to investigate the effects of IV DMT on the power spectrum and signal diversity of human brain activity (6 female, 7 male) recorded via multivariate EEG, and plot relationships between subjective experience, brain activity and drug plasma concentrations across time. Compared with placebo, DMT markedly reduced oscillatory power in the alpha and beta bands and robustly increased spontaneous signal diversity. Time-referenced and neurophenomenological analyses revealed close relationships between changes in various aspects of subjective experience and changes in brain activity. Importantly, the emergence of oscillatory activity within the delta and theta frequency bands was found to correlate with the peak of the experience - particularly its eyes-closed visual component. These findings highlight marked changes in oscillatory activity and signal diversity with DMT that parallel broad and specific components of the subjective experience, thus advancing our understanding of the neurobiological underpinnings of immersive states of consciousness.

Bioequivalence of Carpine Tablets Containing Carbamazepine

2003 ◽  
Vol 19 (5) ◽  
pp. 278-282
Author(s):  
Yahaya Hassan ◽  
Yvonne T Tan ◽  
Kok-Khiang Peh ◽  
Noorizan Abd Aziz ◽  
Ab Fatah Ab Rahman ◽  
...  
Keyword(s):  
Plasma Concentrations ◽  
Bioequivalence Study ◽  
Assay Method ◽  
Rank Test ◽  
Paired Samples ◽  
Period 2 ◽  
Signed Rank ◽  
Elimination Half ◽  
Significant Difference ◽  
Signed Rank Test

Objective: To develop a suitable assay method for carbamazepine and to use this method in the evaluation of a Malaysian-made generic tablet and a commercially available tablet containing carbamazepine for bioequivalence after a single-dose, randomized, 2-period, 2-treatment, 2-sequence crossover study. Method: Eighteen healthy men participated in the bioequivalence study. Each treatment was given as a single 2 × 200-mg dose. Plasma concentrations of carbamazepine were collected for up to 168 hours and assayed using HPLC. Results: The test to reference ratios were found to be 1.05 for maximum concentration (Cmax), 1.02 for AUC(0-t), 0.96 for AUC(t-∞), 1.01 for AUC(0-∞), and 0.99 for elimination half-life. The 90% confidence intervals of the AUC and Cmax parameters were within the range of 0.80–1.25. Wilcoxon signed-rank test for paired samples showed no statistically significant difference between the tmax results. Conclusions: All of the parameters evaluated showed bioequivalence between the 2 formulations.

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