Arzneimittel Forsch
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Arzneimittel Forsch · Jan 2007
Randomized Controlled Trial Comparative StudyComparative pharmacokinetics of two tablet formulations of amoxicillin: bioequivalence assessment.
The aim of the present study was to compare the bioavailability of amoxicillin (CAS 26787-78-0) from two different amoxicillin tablets (Demoksil 1 g tablet as test preparation and 1 g tablet of the originator product as reference preparation). The study was conducted according to an open-label, randomised two-period cross-over design with a wash-out phase of 4-7 days. Blood samples for pharmacokinetic profiling were taken up to 10 h post-dose, and amoxicillin plasma concentrations were determined with a validated LC-MS/ MS method. ⋯ Plasma elimination half-lives (t(1/2)) of 1.64 h (test) and 1.65 h (reference) were determined. Both primary target parameters, AUC(0-infinity) and C(max) were tested parametrically by analysis of variance (ANOVA) and the 90% confidence intervals were between 96.76%-108.46% (AUC(0-infinity)) and 97.80%-111.98% (C(max)). Bioequivalence between test and reference preparation was demonstrated since for both parameters, AUC and C(max) the 90% confidence intervals of the T/R-ratios of logarithmically transformed data were in the generally accepted range of 80%-125%.
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Arzneimittel Forsch · Jan 2007
Randomized Controlled TrialBioequivalence study of a sustained release fixed dose combination capsule containing esomeprazole and domperidone in healthy subjects.
The study was designed to determine the relative bioavailability of two sustained release fixed dose combination (FDC) products of two manufacturers containing esomeprazole (CAS 326602-80-6) 40 mg and domperidone (CAS 57808-66-9) 30 mg in 24 healthy male volunteers. The pharmacokinetics of esomeprazole and domperidone individually after oral administration of tablet formulation has been extensively evaluated in adult volunteers. However, no published data are available regarding the combined pharmacokinetics and bioavailability of this particular FDC. ⋯ These findings clearly indicate that the two products are bioequivalent in terms of rate and extent of drug absorption. Both preparations were well tolerated with no adverse reactions throughout the study.
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Arzneimittel Forsch · Jan 2007
Randomized Controlled TrialProspective controlled cohort studies on long-term therapy of ovairian cancer patients with mistletoe (Viscum album L.) extracts iscador.
Mistletoe extracts such as Iscador are commonly used as complementary/anthroposophic medications for many cancer indications, particularly for solid cancers. The efficacy of this complementary therapy is still controversial. ⋯ Mistletoe extracts Iscador might have the effect of prolonging overall survival of ovarian cancer patients. In the short term, psychosomatic self-regulation increases more markedly under Iscador therapy than under conventional therapy alone.
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Arzneimittel Forsch · Jan 2007
Randomized Controlled Trial Comparative StudyBioequivalence assessment of two capsule formulations of omeprazole in healthy volunteers.
A randomized, single-dose, crossover study was conducted to assess the bioavailability of two omeprazole (CAS 73590-58-6) capsule formulations, Emilok (test) and a commercially available original preparation (reference), under fasting conditions. A 20 mg dose of each formulation was administered to 36 healthy male volunteers with one-week washout period, 17 blood samples were collected over 12 h, plasma omeprazole concentrations were determined by a locally validated high performance liquid chromatography (HPLC) assay, and omeprazole pharmacokinetic parameters were analyzed by the standard non-compartmental method. ⋯ ANOVA revealed significant subject's effect for AUC(0 --> t), AUC(0 --> infinity), Cmax, and t1/2 with a ratio of the inter-subject to intra-subject coefficient of variation of 3.66, 3.92, 1.25, and 1.46, respectively. The results confirm the presence of marked individual variations in the pharmacokinetics of omeprazole and indicate that the two formulations are equivalent in relation to the extent but not the rate of absorption.
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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.