Klaus Schaffler

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In a pilot study based on an open cross-over design involving four phases, the relative bioavailability of the eburnamenine derivative vinpocetine (CAS 42971-09-5) was investigated in 8 healthy volunteers in relation to different times of drug administration relative to food intake. The substance was applied orally as 10 mg film tablets. The areas under the(More)
The present investigation aimed to elucidate the analgesic efficacy of 30 mg of intravenous orphenadrine citrate (CAS 4682-36-4) in a human pain model. Eighteen healthy female and male subjects were enrolled and received single infusions of 30 mg orphenadrine citrate and matching placebo in two periods which were separated by a 1 week washout period. The(More)
Twelve healthy young males volunteered in this pilot-study to test the encephalotropic potency of a deproteinized hemodialysate of calf blood (Actovegin). This compound contains peptides, oligosaccharides and nucleinic acid derivatives, which are supposed to improve transport of glucose and oxygen into cells. The study is based on a placebo-controlled,(More)
OBJECTIVE The aim of this study was to investigate the analgesic efficacy of Neodolpasse, a fixed-dose combination of orphenadrine and diclofenac, compared with those of its single active ingredients in a human pain model. METHODS The study was designed as a randomised, double-blind, placebo-controlled, four-period crossover study. Twenty-four healthy(More)
The major problem in predicting clinical efficacy from animal experimental results and phase I data is the lack of resemblance between the models used and the clinical condition. This problem is complicated by the diversity of the potential mechanisms of action of new compounds. A further question is whether Phase I studies should be used as predictors of(More)
Objective experimental algesimetry was used to assess quantitative differences in analgesic properties between acetylsalicylic acid (ASA, 750 mg) and a special combination of ASA, trilithium citrate and quinine-2 HCl (750 mg, 126 mg, 4.5 mg) in a placebo-controlled double-blind crossover study on nine healthy subjects. Radiant heat stimulation was applied(More)
The effects of two acute doses (1600 mg, 2400 mg) of 2-oxo-pyrrolidine-1-acetamide (piracetam, Normabraïn) on hypoxia resistance were screened vs placebo in a randomized, double-blind 3-way change-over design in 9 healthy male volunteers (mean age: 26.4 +/- 3.5 years; mean body weight: 74.9 +/- 8.4 kg). Psychophysiological measurements were done with the(More)
A randomised, placebo-controlled, double-blind, crossover study was run in 8 healthy, male subjects (mean age 27.3 +/- 2.6 years, mean BW 75.3 +/- 9.7 kg) to demonstrate a possible hypoxia-protective effect of standardised Ginkgo flavone glycosides after subchronical administration. After a 14-days' treatment with Ginkgo bilobae extract (Tebonin)(More)
To assess pharmacodynamic and pharmacokinetic properties of acute, subchronic and withdrawn quazepam, a single-blind, longitudinal study was run in eight male, healthy young volunteers. The design covered a 1-week placebo run-in period, a period with daily oral night-time administration of 15 mg quazepam until a pharmacokinetic steady-state was reached (3(More)
The pharmaceutical industry faces tough times. Despite tremendous advances in the science and technology of new lead identification and optimization, attrition rates for novel drug candidates making it into the clinic remain unacceptably high. A seamless boundary between basic preclinical and clinical arms of the discovery process, embodying the concept of(More)