Arzneimittel Forsch
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Arzneimittel Forsch · Jan 2004
Randomized Controlled Trial Comparative Study Clinical TrialComparison of two different preparations of ibuprofen with regard to the time course of their analgesic effect. A randomised, placebo-controlled, double-blind cross-over study using laser somatosensory evoked potentials obtained from UW-irritated skin in healthy volunteers.
In the treatment of painful conditions the time to onset of a drug's analgesic effect is of great relevance. Plain ibuprofen acid (Ibu, CAS 15687-27-1) is relatively slowly absorbed after oral administration (t(max) is about 90-120 min). If, however, ibuprofen is given in form of a lysine salt, absorption is much quicker. ⋯ The reduction of the amplitudes of the single N1-components by IbuLys was significant in comparison to Plc (p < or = 0.0031), but not in comparison to Ibu. During the time of 5 h after medication the attenuating (analgesic) effect of IbuLys on the amplitude of the P2 component of the LSEPs was stronger than that of Plc (p < or = 0.0053) and stronger than that of Ibu (p < or = 0.0058). In summary IbuLys was significantly superior to Ibu with respect to the onset and extent of the analgesic effect. drugs were used to measure the extent of the analgesic effects. superior to Ibu with respect to the onset and extent of the analgesic effect.
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Arzneimittel Forsch · Jan 2004
Randomized Controlled Trial Multicenter Study Clinical Trial[Efficacy and safety of long-term complementary treatment with standardized European mistletoe extract (Viscum album L.) in addition to the conventional adjuvant oncologic therapy in patients with primary non-metastasized mammary carcinoma. Results of a multi-center, comparative, epidemiological cohort study in Germany and Switzerland].
The purpose of the study was to evaluate the therapeutic efficacy and safety of long-term complementary therapy in primary, non-metastatic mammary carcinoma patients in UICC stage I-III with a standardized European mistletoe extract (Viscum album L., Iscador, "mistletoe extract") given in addition to conventional adjuvant oncologic therapy (i.e. chemo-, radio-, and hormonal therapy; "conventional therapy"). ⋯ The results of the present study confirmed the safety of the complementary therapy of patients with primary, non-metastatic mammary carcinoma with a standardized mistletoe extract and showed considerably fewer ADRs attributed to concurrent conventional therapy, as well as reduced disease and treatment-associated symptoms, and suggested a prolonged overall survival in the mistletoe extract group as compared with controls.
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Arzneimittel Forsch · Jan 2004
Randomized Controlled Trial Comparative Study Clinical TrialBioavailability study of drotaverine from capsule and tablet preparations in healthy volunteers.
The bioavailability of drotaverine (CAS 14009-24-6) was investigated after oral administration of a drotaverine capsule preparation (20 mg Droxa mite) and compared to that of a reference tablet preparation. The preparations were investigated in 23 healthy volunteers, aged between 20 and 27 years, according to a randomised two-way, cross-over design in the fasted state. Blood samples for determination of drotaverine plasma concentrations were collected at pre-defined time points up to 30 h following drug administration. ⋯ AUC was calculated using two different methods. There were no significant differences between the obtained values. Since the 90% CI for both, AUC and Cmax ratios were within the 80-125% interval proposed by the European Agency for the Evalution of Medicinal Products (CPMP) and the Food and Drug Administration, it is concluded that the new drotaverine capsule formulation is therapeutically equivalent to the conventional formulation for both, the extent and the rate of absorption after single dose administration in healthy volunteers.