A comparative study of the antitussive activity of levodropropizine and dropropizine in the citric acid-induced cough model in normal subjects. Levodropropizine is the levo-rotatory (S)-enantiomer of dropropizine, a racemic non-opiate antitussive agent which has been used clinically for many years. Compared with the racemic drug, levodropropizine exhibits in animal models similar antitussive ) of levodropropizine and dropropizine were assessed by using the citric acid-induced cough model in eight normal volunteers. Stimulation tests involved inhalation of individual cumulative doses of citric acid (6.3 to 53.3 mg) which at pre-study assessment had been found to induce reproducibly at least ten coughs over a 30 sec period. Each subject was studied by repeating the citric acid stimulation test four times
Efficacy and tolerability of levodropropizine and dropropizine in children with non-productive cough. The antitussive efficacy and tolerability of dropropizine and of its enantiomer levodropropizine were evaluated in children with non-productive cough; 258 were evaluable for tolerability and 254 for efficacy. Patients randomly received either 1 mg/kg dropropizine or 2 mg/kg levodropropizine orally, three times daily for 3 days. There were statistically significant decreases in the frequency of coughing spells and nocturnal awakenings after both levodropropizine and dropropizine treatments (P < 0.001). Gastro-intestinal symptoms were mild in the two groups; somnolence was twice as frequent in the dropropizine group (10.3% vs 5.3%) and the difference is clinically relevant, though
Enantioselective effects of levodropropizine and dropropizine on psychomotor functions in normal volunteers: a placebo-controlled, double-blind comparative study. Levodropropizine is the l-isomer of dropropizine, a racemic drug widely used as a cough suppressant. Compared with the racemate, levodropropizine retains equal antitussive activity but exhibits considerably lower central nervous system (CNS) depressant effects in animal models. In order to assess whether the same differential pharmacodynamic profile also applies to man, a double-blind placebo-controlled study was carried out to investigate the effects of single oral doses (60 and 120 mg) of levodropropizine and dropropizine on subjective alertness (scored on visual analogue scales), general tolerability and psychomotor function
Sensitive Spectrophotometric Method for Quantitation of Guaifenesin and Dropropizine in Their Dosage Forms Guaifenesin and dropropizine were analyzed through oxidation with periodic acid to give formaldehyde which was allowed to condense with 4-Amino-5-hydrazino-4H [1,2,4]-triazole-3-thiol (AHTT). The condensation product was further oxidized to yield a purple colored compound with maximum absorption at 550 nm. Beer's law was obeyed in the range of 5-45 mug mL(-1) for guaifenesin and 10-80 mug mL(-1) for dropropizine. Both drugs were also successfully determined in their dosage forms.
Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S
Phase Inflammation Cough Rhinitis Drug: diphenhydramine + dropropizine + pseudoephedrine Drug: Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir). Phase 3 Study Design Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Official Title: Multicenter Clinical Trial, Phase III, Controlled, Open, Parallel Group, Randomized, Comparing the Fixed Dose Combination of Diphenhydramine + Dropropizine + Pseudoephedrine and the Combined Use of Dropropizine and Fixed Dose Combination of Pseudoephedrine Hydrochloride + Brompheniramine Maleate Used Orally for Evaluation of Efficacy and Safety in Control Cough