Publications by authors named "Jan Hartstra"
The oral tyramine challenge evaluates the safety of novel monoamine oxidase (MAO) inhibitors when taken with tyramine-containing food or drinks. In its current design, it comprises an extensive series of tyramine escalation steps until a blood pressure threshold is met. Due to the high variation in tyramine bioavailability, and thereby in blood pressure effect, this classical design has various limitations, including safety concerns.
View Article and Find Full Text PDFPurpose: Intravenous amisulpride, a dopamine D/D antagonist, has recently been shown in trials to be an effective antiemetic at low doses. This study was conducted to investigate the metabolism and elimination of a single dose of intravenous C-labeled amisulpride in healthy, adult volunteers.
Patients And Methods: Six healthy male volunteers aged 18-65 years were given a single 10 mg dose of C-labeled amisulpride containing not more than 1.
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.
Objective: To determine the bioequivalence of brivaracetam oral tablet formulations (10, 75, and 100 mg) versus 50 mg oral tablet and to compare the bioavailability of brivaracetam 100 mg intravenous (i.v.) bolus versus 50 and 100 mg tablets, in healthy participants.
View Article and Find Full Text PDFBackground: Approximately one-third of all HIV-infected individuals are coinfected with HCV, many of whom will receive concomitant treatment for both infections. With the advent of direct-acting antivirals (DAAs) for HCV, potential drug interactions between antiretrovirals and DAAs require evaluation prior to co-therapy.
Methods: Three open-label studies were conducted in healthy subjects to assess potential interactions between the investigational first-in-class HCV NS5A replication complex inhibitor daclatasvir and representative antiretrovirals atazanavir/ritonavir, efavirenz and tenofovir disoproxil fumarate.