Publications by authors named "L G De Leede"
The strict intake regimen of cysteamine bitartrate formulations, associated with side effects, is a concern for the treatment compliance in cystinosis therapy. Therefore, there is a need for a cysteamine formulation with an improved pharmacokinetic profile. This study investigated the pharmacokinetics, safety and tolerability of a new sustained-release cysteamine dosage form, PO-001, in healthy volunteers.
View Article and Find Full Text PDFIntroduction: A new combination tablet containing sublingual testosterone and oral buspirone (T+B) was developed to benefit a subgroup of women suffering from female sexual interest/arousal disorder, caused by dysfunctionally overactive sexual inhibition.
Aim: The aim of this study was to compare the effect of food intake on the pharmacokinetics of buspirone, administered as a dual-route, dual-release combination tablet containing 0.5 mg testosterone (T) and 10 mg buspirone (B).
First-in-Human Study of the Safety, Tolerability, Pharmacokinetics and - Preliminary Dynamics of Neuroprotectant 2-Iminobiotin in Healthy Subjects.
Curr Clin Pharmacol
September 2021
Article Synopsis
- 2-iminobiotin (2-IB) is being tested as a neuroprotective agent to reduce brain cell damage after cerebral hypoxia-ischemia, and this study aimed to evaluate its safety and pharmacokinetics in healthy males.
- The randomized, double-blind, placebo-controlled study included healthy males who received varying doses of 2-IB, with results indicating that it was safe and well-tolerated up to doses of 6 mg/kg.
- While 2-IB showed a high clearance rate and linear pharmacokinetics, preliminary pharmacodynamics evaluations in a different model did not show significant effects relevant to its intended use for cerebral hypoxia-ischemia.
Introduction: Female sexual interest/arousal disorder (FSIAD) affects many women worldwide, but pharmacological treatment options are scarce. A new medicine being developed for FSIAD is an on-demand, dual-route, dual-release drug combination product containing 0.5 mg testosterone (T) and 50 mg sildenafil (S), referred to here as T+S.
View Article and Find Full Text PDFInjectable thermogels based on poly(ε-caprolactone-co-lactide)-b-poly(ethylene glycol)-b-poly(ε-caprolactone-co-lactide) (PCLA-PEG-PCLA) containing an acetyl- or propyl endcap and loaded with celecoxib were developed for local drug release. The aim of this study was to determine the effects of the composition of the celecoxib/PCLA-PEG-PCLA formulation on their in vivo drug release characteristics. Furthermore, we want to obtain insight into the in vitro-in vivo correlation.
View Article and Find Full Text PDF