Arzneimittel Forsch
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Arzneimittel Forsch · Jan 2009
Randomized Controlled Trial Comparative StudyComparative bioavailability study of amisulpride tablets in healthy Indian volunteers.
An improved HPLC method was developed and validated for the determination of concentration of amisulpride (CAS 71675-85-9) in human plasma, an attempt to compare the bioavailability of two amisulpride tablet formulations (reference and test) containing 200 mg of amisulpride. Both the formulations were administered orally as a single dose, separated by washout period of 1 week. This HPLC method validated by examining the precision and accuracy for the inter-day and intra-day runs in a linear concentration range of 50-1200 ng/ml. ⋯ The formulations were compared using the parameters like area under the plasma concentration-time curve (AUC0-t), area under the plasma concentration-time curve from zero to infinity (AUC0-infinity), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax). The results indicated that there were no statistically significant differences (P > 0.05) between the logarithmic transformed AUC0-infinity and Cmax, values, between test and reference formulation. The 90% confidence interval for the ratio of the logarithmic transformed AUC0-t, AUC0-infinity, and Cmax were within the bioequivalence limit of 0.8-1.25 and the relative bioavailability of test formulation was 96.82% to that of reference formulation.
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Arzneimittel Forsch · Jan 2009
Randomized Controlled Trial Comparative StudyBioequivalence study of two minocycline capsule formulations in healthy volunteers.
The bioequivalence of two capsule formulations containing 100 mg minocycline was assessed in 12 healthy adult male and female volunteers in a crossover, randomized, single-blind study. The participating volunteers were required to fast overnight and in the next morning and were given orally one capsule of the test drug (Acnez) or one capsule of the reference drug. Blood samples were drawn immediately before taking the drug (control), and at 0.33, 0.67, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, and 60 h after drug administration. ⋯ The 90% confidence intervals (CIs) were 89.26-108.19% for AUC(t), 89.95-107.41% for AUC(inf), and 89.55-105.73% for C(max). Using Wilcoxon matched-pairs test on the original data, there was no statistically significant difference found between the test and the reference drug products for t(max), values. It can be concluded that the two minocycline capsules (test drug and reference drug) are bioequivalent in terms of the rate and extent of absorption.
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Arzneimittel Forsch · Jan 2009
Possible link between history of hypersensitivity to a specific non-steroidal anti-inflammatory drug (NSAID) and positive results following challenge test to alternative NSAIDS.
In subjects with hypersensitivity reactions to non-steroidal anti-inflammatory drugs (NSAIDs), the choice of suitable alternative drugs with the lowest risk of reaction is imperative for therapeutic management. A safe method to exclude drug hypersensitivity is to perform a challenge test for an alternative drug. The present study was conducted to: obtain more information about the safety of NSAIDs; assess the risk of reaction following the administration of a selective or nonselective cyclooxygenase 2 (COX-2) inhibitor in patients with a history of adverse reactions to NSAIDs; investigate if age and/or gender play a role in the susceptibility to develop adverse reactions to NSAIDs. ⋯ In this study, selective COX-2 inhibitors represented the class of NSAIDs less frequently reported as responsible of adverse reaction. These data underline that there is a higher risk to find a positive challenge test to a non-selective COX-2 inhibitor than to a selective one in patients with previous adverse reactions to a non-selective COX-2 inhibitor. Moreover, the data evidence that females could have a higher risk compared to males to develop an adverse reaction to selective COX-2 inhibitors. In conclusion, it appears necessary to pay attention to the kind of NSAIDs reported as the cause of hypersensitivity in anamnesis, because it must be considered a successful guide in choosing the alternative drug to administer to the patient during the challenge test.
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Arzneimittel Forsch · Jan 2008
Randomized Controlled Trial Comparative StudyPharmacokinetics and bioequivalence study of clindamycin hydrochloride formulations after single-dose administration in healthy Chinese male volunteers.
The aim of the present study was to compare the bioavailability of clindamycin (CAS 18323-44-9) from three clindamycin hydrochloride (CAS 21 462-39-5) capsules (clindamycin 75 mg capsule as test 1 preparation, 150 mg capsule as test 2 preparation and a commercially available original 150 mg capsule of the drug as reference preparation) in 24 Chinese healthy male volunteers, aged between 22 and 28. The study was conducted according to a randomized, double-blind, 3-period, 3-treatment, 3-sequence, single-dose, crossover design with a wash-out phase of 7 days. Blood samples for pharmacokinetic profiling were taken up to 14 h post-dose, and clindamycin plasma concentrations were determined with a validated liquid chromatography-electrospray ionization-mass spectrometry (LC-ESI-MS) method. ⋯ Bioequivalence between test and reference preparation was demonstrated for both parameters, AUC(0-infinity) and AUC(0-t). The 90% confidence intervals of the T/R-ratios of logarithmically transformed data were in the generally accepted range of 80%-125%. That means that the two test formulations are bioequivalent to the reference formulation for clindamycin.
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Arzneimittel Forsch · Jan 2008
Efficacy and safety of ambroxol lozenges in the treatment of acute uncomplicated sore throat. EBM-based clinical documentation.
Sore throat is the hallmark of acute pharyngitis. Although usually caused by viral infections, it is frequently treated with antibiotics. Such inappropriate use of antibiotics might best be challenged by offering efficacious and safe symptomatic pain relief instead. ⋯ There was heterogeneity in reporting adverse events: in one later study with less severe baseline pain intensity there was more frequent reporting of hypoaesthesia of the oral cavity and tongue as an untoward phenomenon. In patients with more severe baseline pain this reflection of the medication's pharmacological action was only rarely reported as untoward. It is concluded that lozenges containing 20 mg ambroxol are a safe and efficacious treatment for acute uncomplicated sore throat of recent onset in adult patients.