Arzneimittel Forsch
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Arzneimittel Forsch · Jan 2006
Comparative StudyBioequivalence study of two amoxicillin formulations.
A randomized single-dose crossover study was conducted in 24 healthy male volunteers to compare the bioavailability of two amoxicillin (CAS 26787-78-0) formulations, Glomox tablet (test) and a commercially available original preparation, amoxicillin capsule (reference). One thousand milligram of each formulation were administered after an overnight fast with a washout period of three days. ⋯ The parametric 90 % confidence intervals of the mean of the difference (test-reference) between log-transformed values of the two formulations were 92.61% to 109.50%, 92.83% to 109.12%, and 93.11% to 109.41% for AUC0-->t, AUC0-->infinity, and Cmax, respectively. The results indicate that the two formulations can be considered equivalent with regard to the rate and extent of absorption under fasting conditions.
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Arzneimittel Forsch · Jan 2006
Comparative StudyPharmacological and toxicological testing of the enantiomers of two chiral fomocaine alkylmorpholine derivatives in comparison to their in vitro interactions on drug metabolism in rats.
Between the stereoisomers of amide-type local anaesthetics differences have been noticed with respect to pharmacokinetics and side effects, but not regarding local anaesthetic capacity. Therefore, only S-(-)-ropivacaine has been introduced into clinical practice and with bupivacaine both the racemate and the S-(-)-enantiomer (levobupivacaine) are available by now. Based on this background, the aim of the present study was to evaluate if there are also dissimilarities to be found both in the toxicity and in the effectiveness of the enantiomers of two newly synthesized chiral fomocaine alkylmorpholine derivatives, OW3 and OW13, with an additional C2-chain in 2- or an additional C3-chain in 3-position at the morpholine ring, respectively. ⋯ With both derivatives no clear-cut dissimilarities were noticed in the local anaesthetic capacity of the enantiomers. None of the four compounds caused paresis. Thus, similar to amide-type local anaesthetics, also with the enantiomers of chiral fomocaine alkylmorpholine derivatives differences in pharmacokinetic properties and toxicity could be demonstrated.
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Arzneimittel Forsch · Jan 2006
[Study of the toxicity of povidone-lodine for fibroblast-like cells (BALB-3T3) and primary human chondrocytes].
Povidone-iodine (polyvinyl-pyrrolidone-iodine complex, PVP-iodine, CAS 25655-41-8) is a commonly used antiseptic because of its broad spectrum of antimicrobial effect and its comparatively low allergic risk. It is also used for open joint lavage. Animal and organ culture studies provide controversial results about the risk of cartilage damage due to povidone-iodine. ⋯ From the results it can be concluded that low concentrations of povidone-iodine (< 1%) and short incubation times (< 30 min) have no damaging influence on chondrocytes. Previous studies have reported the antimicrobial effectiveness of low concentrations of povidone-iodine on the reduction of tissue damage by microorganisms. Data from previus studies and the current findings from this investigation support the clinical use of povidone-iodine at low concentrations and short incubation times for antiseptic treatment of cartilage tissues.
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Arzneimittel Forsch · Jan 2006
Randomized Controlled Trial Multicenter StudyEvaluation of the non-inferiority of a fixed combination of thyme fluid- and primrose root extract in comparison to a fixed combination of thyme fluid extract and primrose root tincture in patients with acute bronchitis. A single-blind, randomized, bi-centric clinical trial.
In a single-blind, randomized, bi-centric, prospective study, the non-inferiority of a fixed combination of thyme fluid extract and primrose root fluid extract (Bronchicum Elixir S, fluid test medication) was evaluated by comparison to a fixed combination of thyme fluid extract and primrose root tincture (Bronchcium Tropfen, drops test medication). The patients took either 6 x 5 ml of the fluid test medication (fluid group) or 5 x 1 ml of the drops test medication (drops group) daily. 189 outpatients (121 women, 68 men) suffering from acute, not previously treated bronchitis, lasting for less than 48 h, were randomized and treated with either fluid (94 patients: 66 women, 28 men) or drops (95 patients: 55 women, 40 men) over a time period of 7-9 days. 71 patients were excluded from the per-protocol (PP) collective because of violations regarding examination time points and/or intake of the study medication. The primary outcome criterion was to demonstrate the non-inferiority of the Score (BSS) at the end of the study compared to baseline. ⋯ In the global safety assessment, the tolerability of both medications was rated by about 90% of the patients and by clinical investigators as "good" or "very good". The study demonstrated that the fixed combination of thyme fluid extract and primrose root extract and the combination of thyme fluid extract and primrose root tincture were well tolerated and showed comparable results regarding their efficacy, e.g. decrease of the bronchitis symptoms (primary outcome criterion) and in relief of symptoms (secondary outcome criterion). The results of the study confirm the non-inferiority of the fluid, a combination of thyme fluid extract and primrose root extract when compared to the drops, a combination of thyme fluid extract and primrose root tincture.
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Arzneimittel Forsch · Jan 2006
Randomized Controlled TrialEfficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial.
To assess the efficacy and tolerability of a fixed fluid extract combination of thyme and ivy leaves (thyme-ivy combination) and matched placebo in patients suffering from acute bronchitis with productive cough. ⋯ Oral treatment of acute bronchitis with thyme-ivy combination for about 11 days was superior to pla-