SARS-CoV-2 Neutralization in Convalescent Plasma and Commercial Lots of Plasma-Derived Immunoglobulin.

Introduction: Patients with primary or secondary immunodeficiency (PID or SID) face increased insecurity and discomfort in the light of the COVID-19 pandemic, not knowing if and to what extent their comorbidities may impact the course of a potential SARS-CoV-2 infection. Furthermore, recently available vaccination options might not be amenable or effective for all patients in this heterogeneous population. Therefore, these patients often rely on passive immunization with plasma-derived, intravenous or subcutaneous immunoglobulin (IVIG/SCIG).

Ocular safety of propiverine hydrochloride in elderly patients with primary open- and narrow-angle glaucoma .

Background: Propiverine hydrochloride (P4) is an antimuscarinic drug used in overactive bladder syndrome.

Methods: Two studies were performed: one in 24 patients with open-angle glaucoma (OAG) treated with topical β-blockers, one in 24 patients with narrow-angle glaucoma (NAG) treated with pilocarpine ± topical β-blockers. Patients were treated in randomized, placebo-controlled, double-blind parallel-group fashion (15 : 9 attribution to P4 vs.

Effects of renal insufficiency on the elimination of fluorescein lisicol (NRL972), an investigational marker of hepatic transporter function.

Background: NRL972 (Fluorescein Lisicol), a fluorescent-labelled bile salt, is an investigational marker of hepatic biliary transporter function.

Objective: To investigate the pharmacokinetics (PK) of NRL972 in patients with severe (SRI: creatinine clearance (CLCr)<30 mL/min per 1.73 m2 body surface area (BSA)) and mild-to-moderate renal insufficiency (MRI: 30≤CLCr<80 mL/min) relative to matched controls (CON: CLCr≥90 mL/min).

Effects of advanced age and renal dysfunction on the single- and repeated-dose pharmacokinetics of modified-release flupirtine.

Background: Flupirtine is a nonopioid, central analgesic without antipyretic or antiphlogistic properties. Flupirtine-MR is an oral modified-release formulation with a 100 mg fast-input and a 300 mg portion with slow protracted release.

Methods: Single- (D01) and repeated-dose (D03-D09) pharmacokinetics of 400 mg flupirtine-MR were investigated in patients with severe renal dysfunction (REN: N: 12; 21 50 years of age; creatinine clearance (CLCr)≤30 mL/min per 1.

No relevant cardiac, pharmacokinetic or safety interactions between roflumilast and inhaled formoterol in healthy subjects: an open-label, randomised, actively controlled study.

Background: Roflumilast is an oral, selective phosphodiesterase 4 inhibitor with anti-inflammatory effects in chronic obstructive pulmonary disease (COPD). The addition of roflumilast to long-acting bronchodilators improves lung function in patients with moderate-to-severe COPD. The present study investigated drug-drug interaction effects between inhaled formoterol and oral roflumilast.

Effects of hepatic dysfunction on the single-dose pharmacokinetics of fesoterodine.

Fesoterodine, a new antimuscarinic for the treatment of overactive bladder, is rapidly and extensively hydrolyzed by nonspecific esterases to its principal active moiety, 5-hydroxymethyl tolterodine (5-HMT). The elimination of 5-HMT involves metabolism and renal excretion. The plasma and urinary pharmacokinetics of 5-HMT and its inactive carboxy (SPM 5509), N-desisopropyl (SPM 7789), and carboxy-N-desisopropyl (SPM 7790) metabolites were investigated after a single oral dose of 8 mg of fesoterodine in 8 male subjects with moderate hepatic cirrhosis (Child-Turcotte-Pugh class B) and 8 matched healthy controls.

Efficacy and safety of ambroxol lozenges in the treatment of acute uncomplicated sore throat. EBM-based clinical documentation.

Sore throat is the hallmark of acute pharyngitis. Although usually caused by viral infections, it is frequently treated with antibiotics. Such inappropriate use of antibiotics might best be challenged by offering efficacious and safe symptomatic pain relief instead.

Steady-state pharmacokinetics of roflumilast and roflumilast N-oxide in patients with mild and moderate liver cirrhosis.

Background: Roflumilast and its primary N-oxide metabolite are targeted phosphodiesterase 4 (PDE4) inhibitors with similar in vivo potency. Roflumilast is being developed for the treatment of inflammatory airway diseases such as chronic obstructive pulmonary disease and asthma.

Objective: To investigate the effects of mild and moderate liver cirrhosis on the steady-state pharmacokinetics of roflumilast and roflumilast N-oxide.

Bioequivalence of a novel oral metronidazole formulation.

The plasma pharmacokinetics of metronidazole (CAS 443-48-1) and its active OH-metabolite (CAS 4812-40-2) were investigated in 16 healthy volunteers after the oral administration of single oral doses of 500 mg metronidazole by means of a novel (test, T) and reference formulation (reference, R). The trial was conducted according to a randomised, controlled, open, within-subject cross-over design with two periods one week apart for wash-out. A single oral dose of 500 mg metronidazole by means of the test formulation T (Vagimid Dragees) resulted in a geometric mean C(max) of 10649 ng/ mL (CV: 0.

Bioequivalence of a novel high-dose oral formulation of alpha-dihydroergocryptine.

The plasma pharmacokinetics of alpha-dihydroergocryptine (DHEC, CAS 14271-05-7) were investigated in 24 patients with Parkinson disease after the administration of repeated oral doses of 40 mg DHEC twice daily by means of a novel 40 mg DHEC tablet (Almirid 40 mg test T) and an established 20 mg DHEC tablet (Almirid 20 mg - reference R). The trial was conducted according to a randomised, controlled, open, within-subject cross-over design; steady-state was established by means of a stepwise up-titration from 5 to 40 mg b.i.

Single dose pharmacokinetics of alpha-dihydroergocryptine in patients with moderate to severe renal insufficiency.

Aim: This study was carried out to evaluate the pharmacokinetic profile of alpha-dihydroergocryptine (CAS 14271-05-7, DHEC, Almirid) in plasma and urine in patients with moderately to severely impaired renal function (creatinine clearance < 30 ml.min-1.1.

Efficacy and tolerability of ambroxol hydrochloride lozenges in sore throat. Randomised, double-blind, placebo-controlled trials regarding the local anaesthetic properties.

Unlabelled: Two confirmatory clinical trials were performed to investigate the efficacy and tolerability of ambroxol lozenges at doses of 20 mg and 30 mg relative to placebo in relieving the symptoms of sore throat of at least moderately severe intensity in patients suffering from oro-pharyngeal catarrh accompanied by pain on swallowing, feeling of scratchiness, burning and urge to cough.

Objective: Description and comparison of the efficacy and tolerability of lozenges containing 20 mg or 30 mg ambroxol hydrochloride (trans-4-[(2-amino-3,5-dibrom-benzyl)amino]cyclohexano hydrochloride, CAS 18683-91-5) in relieving acute sore throat, in comparison to placebo.

Design: Two similar, multi-centre, prospective, placebo-controlled, randomised, double-blind trials involving three days of treatment with up to 6 lozenges containing 20 or 30 mg ambroxol hydrochloride per day.

Local anaesthetic properties of ambroxol hydrochloride lozenges in view of sore throat. Clinical proof of concept.

Unlabelled: Acute oro-pharyngeal catarrh is characterised by mild to severe sore throat, such as pain on swallowing, feeling of scratchiness, burning and urge to cough. The present study was conducted to explore whether the test compound is going to show clinical relevance and is a suitable medication for the relief of these symptoms.

Objective: Description and comparison of the efficacy and tolerability of lozenges containing 20 mg ambroxol hydrochloride (trans-4-[(2-amino-3,5-dibrombenzyl)amino]cyclohexano hydrochloride, CAS 18683-91-5) in relieving acute sore throat, in comparison to placebo.