Examples of using Single-dose study in English and their translations into Slovak
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Results of a single-dose study in patients with end-stage renal disease(ESRD) indicate that the rate of elimination of rilonacept was not decreased.
Heart-rate corrected QT interval using Fridericia's correction(QTcF) was evaluated in a randomized, placebo and active(moxifloxacin 400 mg)controlled cross-over, single-dose study in 47 healthy subjects.
In a single-dose study in healthy subjects, the administration of famotidine 10 hours prior to a single dose of SPRYCEL reduced dasatinib exposure by 61%.
The potential for dermal transfer of oxybutynin from a treatedperson to an untreated person was evaluated in a single-dose study where subjects dosed with Kentera engaged in vigorous contact with an untreated partner for 15 minutes, either with(N=14 couples) or without(N=12 couples) clothing covering the application area.
In a single-dose study, there were no clinically significant effects on retigabine AUC in volunteers with mild hepatic impairment(Child-Pugh score 5 to 6).
However, in an in vivo single-dose study in conscious telemetered monkeys, there were no changes in QT interval or ECG wave form.
In a single-dose study, half life was doubled in the single patient with severe hepatic impairment(Child Pugh Class C), indicating a potential for a much greater degree of accumulation.
In a single-dose study in rats, a semi-synthetic insulin human in a formulation with 400 IU/ml and excipients identical to the Insuman Implantable 400 IU/ml formulation was administered by intraperitoneal injection.
In a single-dose study, the pharmacokinetics of silodosin was not altered in nine patients with moderate hepatic impairment(Child-Pugh scores 7 to 9), compared to nine healthy subjects.
A single-dose study of SIRTURO in 8 subjects with moderate hepatic impairment(Child-Pugh B) demonstrated exposure to bedaquiline and M2(AUC672h) was 19% lower compared to healthy subjects.
In a single-dose study in healthy volunteers and subjects with end stage renal disease, the retigabine AUC was increased by approximately 100% in the subjects with end stage renal disease relative to healthy volunteers.
In a single-dose study in patients with type 2 diabetes, treatment with 300 mg before a mixed meal delayed intestinal glucose absorption and reduced postprandial glucose through both a renal and a non-renal mechanism.
In a single-dose study, retigabine was eliminated more slowly by healthy elderly volunteers(66 to 82 years of age) relative to healthy young adult volunteers, resulting in a higher AUC(approximately 40 to 50%) and longer terminal half-life(30%)(see section 4.2).
In a single-dose study, exposure to silodosin(unbound) in subjects with mild(n=8) and moderate renal impairment(n=8) resulted, on average, in an increase of Cmax(1.6-fold) and AUC(1.7-fold) relative to subjects with normal renal function(n=8).
The results of a single-dose study showed that in young adult volunteers, retigabine Cmax was approximately 65% higher in females than in males, and in elderly volunteers(66 to 82 years of age), retigabine Cmax was approximately 75% higher in females compared with males.
In a second single-dose study in subjects with end stage renal disease receiving chronic haemodialysis(n= 8), initiation of dialysis at approximately 4 hours after a single dose of retigabine(100 mg) resulted in a median reduction in retigabine plasma concentrations of 52% from the start to end of dialysis.
Hepatic impairment In a single-dose study(800 mg) in 12 patients and a multiple-dose study(800 mg) in 13 patients with mild to severe hepatic insufficiency(Child Pugh Class A, B and C), the Cmax, AUC and t1/ 2 of telithromycin were similar compared to those obtained in age- and sex-matched healthy subjects.
A single-dose study in subjects with varying degrees of liver cirrhosis(Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity.
In single-dose studies in healthy volunteers, no interactions were observed between entacapone and imipramine or between entacapone and moclobemide.
The following dosage recommendations are based on single-dose studies in a small number of patients with renal impairment.
Rader said the safety profile appears goodso far,"but we must remember these were single-dose studies.".
There is no specific experience in the management of lenalidomide overdose in patients, although in dose-ranging studies some patients were exposed to up to 150 mg, and in single-dose studies, some patients were exposed to up to 400 mg.
In a single-dose clinical study, radiolabeled(14C) anidulafungin(~88 mg) was administered to healthy subjects.
The second paediatric trial was a multicenter, double-blind, double-dummy, randomised, parallel group,active control, single-dose non-inferiority study, comparing i. v. palonosetron 1 µg/kg, max.
The second paediatric trial was a multicenter, double-blind, double-dummy, randomised, parallel group,active control, single-dose non-inferiority study, comparing intravenous palonosetron(1 μg/kg, max 0.075 mg) versus intravenous ondansetron.
The second paediatric, trial was a multicenter, double-blind, double-dummy, randomised, parallel group,active control, single-dose non-inferiority study, comparing intravenous palonosetron(1 mcg/kg, max 0.075 mg) versus intravenous. ondansetron.