Arzneimittel Forsch
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Arzneimittel Forsch · Dec 2012
Randomized Controlled TrialKetorolac tromethamine improves the analgesic effect of hyoscine butylbromide in patients with intense cramping pain from gastrointestinal or genitourinary origin.
The symptomatic treatment of pain associated with spasm of gastrointestinal or genitourinary origin can include the use of spasmolytic agents and/or non-steroidal anti-inflammatory drugs. However, the evidence of a superior effectiveness of combination in comparison with individual drugs is scarce and controversial. ⋯ Conversely, when treatments were grouped by pain intensity, ketorolac/hyoscine butylbromide combination showed a significant better pain relief profile than hyoscine butylbromide alone in pain intensity ≥7, but not <7. Data indicate that the oral ketorolac/hyoscine butylbromide mixture could be a better option than hyoscine butylbromide alone in the treatment of some acute intense cramping painful conditions.
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Arzneimittel Forsch · Mar 2012
Randomized Controlled Trial Comparative StudyComparative bioequivalence study of leflunomide tablets in Indian healthy volunteers.
The pharmacokinetics of teriflunomide [CAS No. 163451-81-8], the metabolite of leflunomide [CAS No. 75706-12-6] has been evaluated in adult human volunteers after oral administration of tablet formulation. However, no published data is available regarding the bioavailability of this in the Indian population. In light of the above, a study was designed to carry out a bioequivalence study of 2 preparations of leflunomide 20 mg in healthy Indian male volunteers.24 healthy male volunteers (age, 25±4.1 years; weight, 57.58±7.01 kg) were enrolled in this study. ⋯ The results indicated that there are no statistically significant differences between the 2 products in either the mean concentration-time profiles or in the obtained pharmacokinetic parameters. 90% confidence limits for the log transformed data of Cmax, AUC0-t, AUC0-∞. were within the acceptable range of 0.80-1.25. The results indicate that the 2 products are bioequivalent in terms of rate and extent of drug absorption. Both the preparations were well tolerated with no adverse reactions throughout the study.
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Arzneimittel Forsch · Feb 2012
Randomized Controlled TrialPharmacokinetics, pharmacodynamics, and tolerability of a generic formulation of exenatide: a randomized, open-label, single- and multiple-dose study in healthy Chinese volunteers.
A randomized, open-label, dose-escalating study was designed to assess the pharmacokinetics, pharmacodynamics and tolerability of single and multiple subcutaneous administrations of exenatide in 24 healthy Chinese volunteers. The effects of gender on the pharmacokinetics of exenatide were also evaluated. Subjects were randomized to receive a single and multiple subcutaneous doses of 5 or 10 μg of exenatide. ⋯ No significant gender differences were noted for pharmacokinetic variables. Both exenatide doses were associated with significant reductions in serum glucose levels. Adverse events were mainly of gastrointestinal origin and their incidence was dose-dependent.
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Arzneimittel Forsch · Jan 2011
Randomized Controlled TrialInhibitory effect of procaterol on exercise dynamic lung hyperinflation during the 6-min walk test in stable patients with chronic obstructive pulmonary disease.
The purpose of this study was to evaluate the inhibitory effect of procaterol (procaterol hydrochloride, CAS 62929-91-3) on exercise dynamic lung hyperinflation during the 6-min walk test (6MWT) in stable chronic obstructive disease (COPD) patients. Fourteen patients with stable COPD who were referred to our clinic between July 2008 and October 2009 were evaluated in this study. After the inhalation of procaterol, values for the lung function test, including vital capacity, inspiratory capacity, forced vital capacity, and FEV1/FEV1pred showed a significant improvement. ⋯ The Borg scale increased significantly during the 6MWT and was attenuated after inhaling procaterol hydrochloride, though the difference between the two groups was not statistically significant. In the present study, there was a significant attenuation in exercise dynamic lung hyperinflation, suggesting the important role of the beta2-receptor agonist procaterol in the treatment of COPD. It is therefore likely that most patients with COPD may derive considerable benefit from bronchodilator therapy with procaterol.
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Arzneimittel Forsch · Jan 2011
Randomized Controlled Trial Comparative StudyComparative in vitro dissolution and in vivo bioequivalence of two diclofenac enteric coated formulations.
The aim of this study was the comparison of in vitro dissolution and in vivo bioavailability of two different brands of diclofenac sodium (CAS 15307-86-5) enteric coated tablets in healthy male Iranian volunteers in a single-dose, randomized, open-label, single blind study, which was conducted according to a crossover design in healthy volunteers. A washout interval of two weeks was selected between administrations to each subject in this study. Serial venous blood samples over 10 h after each administration to measure diclofenac sodium concentration in serum were obtained, and placed into tubes containing sodium heparin. ⋯ Results show that the 90% confidence intervals for the ratio of test and reference products in Cmax (101.4-114.9%), AUC(0)tau (96.3-109.1%) and AUC(0)infinity (94.7-107.3%) were all within the 80-125% interval proposed by the FDA and EMA. Both formulations released > 80% of drug within 30 min in buffer pH = 6.8 medium. Therefore the diclofenac sodium enteric coated tablets of the test and reference formulations are bioequivalent in terms of rate and extent of absorption.