This investigation was carried out to evaluate the bioavailability of a new suspension formulation of cefixime (100 mg/5 ml), Winex, relative to the reference product, Suprax (100 mg/5 ml) suspension. The bio-availability study was carried out in 24 healthy male volunteers who received a single oral dose (200 mg) of the test (A) and the reference (B) products on 2 treatment days after an overni...

A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibili...

Introduction. The aim of the study was an analysis of pharmacokinetics and PK/PD parameters Cmax/MIC and AUC/MIC for ciprofloxacin in intensive care unit patients. Material and methods. Patients (n=3) received ciprofloxacin intravenously at 400 mg/ 8 h. Blood samples were collected on day 1st of the ciprofloxacin therapy. Plasma drug concentrations were measured by HPLC-UV method. Results. The ...

A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibili...

In this study, the modern tool of machine learning is used to address an old problem from a new perspective. Traditionally, scientific basis for determining bioequivalence based on pharmacokinetic comparison, specifically rate and extent absorption between two products. Even though it generally agreed that peak plasma concentration (Cmax) should be measure absorption, several studies have raise...

Intramuscular (IM) epinephrine via autoinjector has suboptimal compliance/use; alternatives are needed. We compared bioavailability and cardiovascular effects of intranasal (IN) nasal spray versus IM epinephrine. This open-label, randomized, 5-treatment, 5-way crossover study included 25 healthy participants aged 19–45 years. Epinephrine administrations were: 6.6-mg IN (1x6.6-mg), 4.4-mg (2x2.2...

OBJECTIVE Evaluate the pharmacokinetics (PK), safety, and tolerability of single doses of once-daily USL255, Qudexy XR (topiramate) extended-release capsules, over a wide dosing range. METHODS Two single-dose, phase I studies in healthy adults were used to evaluate the PK profile and maximum tolerated dose (MTD) of USL255 from 25-1,400 mg. Standard PK parameters assessed included area under t...

Our aim was to simultaneously investigate 2 techniques for in vivo sampling of peripheral compartment pharmacokinetics after systemic administration of acetylsalicylic acid. Ten volunteers were given 2 g acetylsalicylic acid orally. Blood samples and dialysates from 4 microdialysis probes inserted in the dermis of the forearm were collected for 5 h and suction blisters were raised 1-3 h after d...

Understanding seasonal changes in photosynthetic characteristics of canopy leaves is indispensable for modeling the carbon balance in forests. We studied seasonal changes in gas exchange characteristics that are related to the temperature dependence of photosynthesis in canopy leaves of Quercus crispula Blume, one of the most abundant species in cool-temperate forests in Japan. Photosynthetic r...

Bioanalytical data from a bioequivalence study were used to develop limited-sampling strategy (LSS) models for estimating the area under the plasma concentration versus time curve (AUC) and the peak plasma concentration (Cmax) of 4-methylaminoantipyrine (MAA), an active metabolite of dipyrone. Twelve healthy adult male volunteers received single 600 mg oral doses of dipyrone in two formulations...