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Evaluation of novel starch acetate-diltiazem controlled release tablets in healthy human volunteers.
TLDR
The moderate formulation and commercial reference tablet showed similar in vitro release profiles and diltiazem concentrations in plasma and in conclusion, direct compression starch acetate formulations control drug release in humans. Expand
Brain 5-HT2A receptor occupancy of deramciclane in humans after a single oral administration – a positron emission tomography study
TLDR
Deramciclane penetrates the blood-brain barrier in humans and binds to the 5-HT2A receptors in the frontal cortex in a saturable manner in vivo, indicating a non-5- HT2A receptor binding component of this radioligand in frontal cortex. Expand
Site dependent bioavailability and metabolism of levosimendan in dogs.
TLDR
It can be concluded that the bioavailability of levosimendan is not affected by site specific administration, and the bacteria or enzymes responsible for the metabolism are located in the lower parts of the gastrointestinal tract. Expand
Deramciclane in the treatment of generalized anxiety disorder: A placebo-controlled, double-blind, dose-finding study
TLDR
Deramciclane 60 mg/day showed significant evidence of efficacy for the treatment of GAD in adult patients, and was safe and well-tolerated up to the 60mg/day dose over an 8-week period. Expand
Pharmacokinetics and safety of deramciclane during multiple oral dosing.
TLDR
The pharmacokinetics of deramciclane is linear over the dose range of 10 - 60 mg at steady-state and the slight non-linearity within the dose levels during repeated administration of seven days was regarded as clinically irrelevant. Expand
The single dose pharmacokinetics and safety of deramciclane in healthy male volunteers
TLDR
The pharmacokinetics and tolerability of a new putative non‐benzodiazepine type anxiolytic compound deramciclane was studied in two consecutive studies and was safe, and was well tolerated at each dose level. Expand
Comparative pharmacokinetics of deramciclane in rat, dog, rabbit and man after the administration of a single oral dose of 3 mg kg-1
TLDR
The comparative pharmacokinetic study of deramciclane indicated an intensive biotransformation in all species although the rate of biotranformation appeared to be species-dependent. Expand
Biopharmaceutics: Different Absorption Profiles of Deramciclane in Man and in Dog
TLDR
The dog model for predicting the oral absorption of deramciclane, a novel anxiolytic compound, as a model acid‐labile drug, is studied in man and beagle dogs after administration of conventional capsules and enteric coated tablets. Expand
Pharmacokinetics of deramciclane in dogs after single oral and intravenous dosing and multiple oral dosing
TLDR
It is suggested that the metabolic capacity was not sufficient to eliminate deramciclane in a linear manner with increasing dose as the AUC0–∞ increased disproportionally to the dose after both intravenous and oral dosing. Expand
Influence of food on the oral bioavailability of deramciclane from film-coated tablet in healthy male volunteers.
TLDR
The 24 and 31% increase in C(max) and AUC(0-infinity) of deramciclane, respectively, under fed condition is modest and probably has no clinical significance since it is relatively small compared to the inter-individual variability of these parameters. Expand
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