Investigation of the therapeutic equivalence of different galenical preparations of O-(beta-hydroxyethyl)-rutosides following multiple dose peroral administration.

Oxerutins (O-(beta-hydroxyethyl)-rutosides, HR, Venoruton) are available in different releasing galenical formulations for the treatment of chronic venous insufficiency (CVI). In order to investigate the biopharmaceutical relevance of the releasing properties of the galenical forms the therapeutic efficacy between the commercially available forms was investigated (500 mg sustained release film tablets, 300 mg sustained release film tablets, 300 mg normally releasing capsules) in comparison to an aqueous solution and placebo. In total 100 female patients with CVI grade II participated.

Influences of dimethindene maleate in a new formulation on oculo and psychomotor performance using the oculodynamic test (ODT) in volunteers.

Most antihistamines are assumed to possess a more or less pronounced sedative potential in addition to their antihistaminic properties. Therefore, a single-blind three-way crossover study was designed to assess the influence of single-dose dimethindene maleate (new "once a day formulation") on vigilance and performance vs. loratadine as reference and vs.

Evaluation of the local anaesthetic activity of dimetindene maleate by means of laser algesimetry in healthy volunteers.

Dimetindene maleate (DMM, Fenistil, CAS 3614-69-5) a specific H1-receptor antagonist, is therapeutically used for the treatment of respiratory allergies, urticaria, itching dermatoses and generally pruritic sensations occurring with various diseases. As it exhibits local anaesthetic activity in the rabbit cornea and the local anaesthetic activity of a couple of H1-antagonists was found to be linearly correlated to the H1-potency represented by the pA2-values--and dimethindene maleate demonstrates a high pA2-value--it seemed worth investigating the local anaesthetic potency in man making use of an objective and well validated pain model, the Laser algesimetry. The study was carried out with 24 healthy volunteers in a double-blind placebo- and reference-controlled, randomized, cross-over design.