[Antisecretory effect of the H2-histamine receptor antagonist ranitidine in water-soluble tablets and film-coated tablets. Results of a randomized, placebo-controlled crossover study in humans].
This clinico-pharmacological trial aimed to prove equivalence between the known film-coated tablets of ranitidine (Sostril Filmtabletten) and the novel dispersible tablets for the preparation of a drinkable solution (Sostril Aquatabs) on a pharmacodynamic level. Therefore, the influence of single oral doses of the two ranitidine preparations (2 X 150 mg p.e.m. each) and placebo on the gastric hydrogen ion concentration was studied in 12 healthy volunteers using a randomized cross-over design. pH-values of the gastric juice were measured and recorded continuously for 24 h. Median pH-values for the entire study period were 2.20, 2.15 and 1.40 for dispersible tablets, filmcoated tablets and placebo, respectively. During the night-time median pH-values of 3.45 for both ranitidine preparations and 1.40 for placebo were calculated. From these results it can be concluded that the novel dispersible tablets are equivalent to the ranitidine filmcoated tablets with regard to their pharmacodynamic potency.
Witzel
L
L
DRK-Krankenhaus Mark Brandenburg, Berlin.
Röhmel
J
J
D000328:Adult; D005260:Female; D005744:Gastric Acid / Q000378:metabolism; D005753:Gastric Mucosa / Q000187:drug effects / Q000378:metabolism*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D016032:Randomized Controlled Trials as Topic; D011899:Ranitidine / Q000008:administration & dosage / Q000494:pharmacology*; D013607:Tablets; D013608:Tablets, Enteric-Coated
D013607:Tablets; D013608:Tablets, Enteric-Coated; D011899:Ranitidine
Antisekretorische Wirksamkeit des H2-Histaminrezeptor-Antagonisten Ranitidin in Form von wasserlöslichen Tabletten und Filmtabletten. Ergebnisse einer randomisierten, Plazebo-kontrollierten Cross-over-Prüfung an Probanden.