Pharmacokinetic and pharmacodynamic comparison of subcutaneous intramuscular leuprolide acetate formulations in male subjects.

Background: The aim of this study was to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of two distinct formulations of leuprolide acetate (LA); subcutaneous (SC) injection and intramuscular (IM) injection.

Methods: A total of 32 healthy men were randomized to receive a single 7.5 mg injection of SC-LA ( = 16) or IM-LA ( = 16) in this phase I, open-label, parallel-group study.

Cardiac safety of Modified Vaccinia Ankara for vaccination against smallpox in a young, healthy study population.

Background: Conventional smallpox vaccines based on replicating vaccinia virus (VV) strains (e.g. Lister Elstree, NYCBOH) are associated with a high incidence of myo-/pericarditis, a severe inflammatory cardiac complication.

Omalizumab protects against allergen- induced bronchoconstriction in allergic (immunoglobulin E-mediated) asthma.

Background: Omalizumab has been shown to suppress responses to inhaled allergens in allergic asthma patients with pretreatment immunoglobulin E (IgE) ≤700 IU/ml. To extend current dosing tables, we evaluated the potential of high omalizumab doses to block allergen-induced bronchoconstriction in patients with higher IgE levels.

Methods: Asthmatic adults (18-65 years; body weight 40-150 kg) were divided into groups according to screening IgE (group 1: 30-300 IU/ml; group 2: 700-2,000 IU/ml) and randomized 2:1 to omalizumab/placebo every 2 or 4 weeks for 12-14 weeks.

Pharmacokinetics and safety of aclidinium bromide in younger and elderly patients with chronic obstructive pulmonary disease.

Objective: To investigate the pharmacokinetics, safety and tolerability of aclidinium bromide 200 μg and 400 μg after a single dose and repeated once-daily doses in younger and elderly patients with moderate or severe chronic obstructive pulmonary disease (COPD).

Methods: Younger (40-59 years; n = 12) and elderly (≥ 70 years; n = 12) patients were treated with aclidinium via the Genuair® inhaler. Patients received once-daily aclidinium 200 μg for 3 days; after a 7-day washout period, patients received once-daily aclidinium 400 μg for 3 days.

Reduction of dietary fat absorption by the novel gastrointestinal lipase inhibitor cetilistat in healthy volunteers.

Aims: To assess the efficacy, pharmacodynamics, safety and tolerability of a range of doses of cetilistat, a novel inhibitor of gastrointestinal lipases, in healthy volunteers.

Methods: Three Phase I, randomized, placebo-controlled, parallel-group studies were conducted. Enrolled subjects in the three studies (n = 99) received a controlled calorie diet (total intake 2160 calories daily, 30% from fat).

Evaluation of the CCK-4 model as a challenge paradigm in a population of healthy volunteers within a proof-of-concept study.

Rationale: Experimental panic induction with cholecystokinin-tetrapeptide (CCK-4) has been established as a model to study the pathophysiology of panic disorder and might serve as a tool to asses the antipanic potential of novel anxiolytic compounds. However, assessment of CCK-4-induced panic does not follow consistent rules.

Objectives: To provide a basis for the use of the CCK-4 model in proof-of-concept studies, we investigated CCK-4-induced panic according to different criteria in 85 healthy volunteers who underwent a CCK-4 bolus injection.

Comparative pharmacokinetics and pharmacodynamics of a new sustained-release growth hormone (GH), LB03002, versus daily GH in adults with GH deficiency.

Context: LB03002 is a novel sustained-release GH preparation administered once weekly.

Objective: Our objective was to examine the pharmacokinetics, pharmacodynamics, and safety of LB03002 vs. daily GH.

Saterinone: A New Dual-Action Drug in the Acute Management of Chronic Heart Failure.

A new dual-action drug called saterinone combines both alpha-1 blocking vasodilatory property and phosphodiesterase III inhibition--mediated inotropism. A placebo-controlled, randomized, double-blind study was performed in 12 patients with severe congestive heart failure. Either 2 &mgr;g center dot kg center dot min(minus sign1) saterinone (n = 8) or placebo (n = 4) was injected intravenously over 3 h at rest.