Arzneimittel Forsch
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Arzneimittel Forsch · Jan 2007
Randomized Controlled Trial Multicenter Study Comparative Study[Comparative clinical study of two dexamethasone phosphate-containing ophthalmics].
For the drug application of the already known active ingredient dexamethasone dihydrogen phosphate disodium salt (CAS 2392-39-4) for ocular use clinical data on the efficacy and safety were required by the drug regulatory agency. The comparison of the pharmaceutical properties had already shown that no differences in clinical use had to be expected. The results of a double-blind, randomised, comparative clinical study on 210 patients prove that no differences between test and comparator product could be observed. This case shows that the demand for clinical trials to proof therapeutic equivalence should be done with a sense of proportion related to the specific situation.
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Arzneimittel Forsch · Jan 2007
Randomized Controlled Trial Comparative StudyBioequivalence study of a fixed dose combination of nitazoxanide and ofloxacin in Indian healthy volunteers.
The pharmacokinetics of nitazoxanide (CAS 55981-09-4) and ofloxacin (CAS 82419-36-1) has been extensively evaluated in adult human volunteers individually after oral administration of tablet formulation. However, no published data is available regarding the combined pharmacokinetics and bioavailability of this particular fixed dose combination. In light of the above, a clinical study was designed to evaluate the bioequivalence of two fixed dose combination (FDC) products of two manufacturers containing nitazoxanide 500 mg and ofloxacin 200 mg in healthy Indian male volunteers. ⋯ Thus, these findings clearly indicate that the two products are bioequivalent in terms of rate and extent of drug absorption. Both the preparations were well tolerated with no adverse reactions seen throughout the study.
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Arzneimittel Forsch · Jan 2007
Randomized Controlled Trial Multicenter StudyEvaluation of efficacy and tolerability of a fixed combination of dry extracts of thyme herb and primrose root in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled multicentre clinical trial.
The objective of the study was to assess the efficacy and tolerability of a fixed combination of dry extracts of thyme herb and primrose root (thyme-primrose combination) and matched placebo in patients suffering from acute bronchitis with productive cough. ⋯ Oral treatment of acute bronchitis with thyme-primrose combination for about 11 days was superior to placebo in terms of efficacy. The treatment was safe and well tolerated.
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Arzneimittel Forsch · Jan 2007
Randomized Controlled TrialLidocaine 8 mg sore throat lozenges in the treatment of acute pharyngitis. A new therapeutic option investigated in comparison to placebo treatment.
An acute pharyngitis is characterised by mild to severe sore throat mostly accompanied by inflammation, throat pain, pain on swallowing, and burning. This randomised, double-blind, placebo-controlled phase III study was conducted for comparison of the efficacy and safety of a newly developed lidocaine (2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide, CAS 137-58-6) 8 mg lozenge formulation (Trachisan Halsschmerztabletten) for the treatment of acute sore throat not necessarily to be treated with antibiotics. 240 patients of both genders were enrolled. The study was performed in a single centre setting and consisted of two parts. ⋯ Pain relief, minimum pain intensity, meaningful pain relief and the time of onset of meaningful pain relief as well as the assessments of global efficacy underlined the superiority of the treatment with lidocaine 8 mg sore throat lozenges. Global tolerability of the verum treatment was rated as "good" or "very good" in the majority of cases, the number of study drug related adverse events was low and evenly distributed to both treatment groups. Therefore, the results of the trial emphasise lidocaine 8 mg sore throat lozenges to be a favourable option in the treatment of pain symptoms of an acute sore throat.
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Arzneimittel Forsch · Jan 2007
Randomized Controlled Trial Comparative StudyBioeqivalence assessment of two domperidone 1 tablet formulations.
A randomized, single-dose, crossover study was conducted to assess the bioavailability of two domperidone (CAS 57808-66-9) tablet formulations, Domperidone (test) and a commercially available original preparation (reference) under fasting conditions. A 10 mg dose of each formulation was administered to 36 healthy male volunteers with a one-week washout period, 17 blood samples were collected over 48 h, plasma concentrations of domperidone were analyzed by a locally validated LC-MS-MS assay, and the pharmacokinetic parameters were determined by the standard non-compartmental method. ⋯ ANOVA revealed significant subject's effect for AU4C(0 --> t), AUC((0 -->infinity), C(max), and t1/2 with a ratio of the inter-subject to intra-subject coefficient of variation of 2.10, 1.55, 1.10, and 1.02, respectively. The results indicate that the two formulations are equivalent in relation to the extent and rate of absorption and confirm the previously reported marked intra-individual variations in the pharmacokinetics of domperidone.