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Background Several conditions require treatment with alkalinising agents. The objective is to restore the homeostasis on various parameters or stabilise some urine parameters. The agents used currently have to be administered several times a day in order to maintain the effect but have a bad gastro-intestinal tolerability, both leading to bad compliance. A new formulation in the form of granules (ADV7103) has been developed to limit the administration to 2 intakes daily and improve gastro-intestinal tolerability. Methods A randomized, placebo-controlled, double-blind, two-period cross-over study has been conducted to evaluate the pharmacodynamics, safety and tolerability of repeated oral doses of ADV7103 at three dose levels, in 8 subjects. The effect was evaluated on urine pH on the first morning urines and on 12 fresh urine collections of 2 hours for 24 hours, after 4 and 5 days of treatment. The safety and tolerability was evaluated. Results Urine pH increased proportionally to the dose administered ( Fig. 1 ). All doses administered demonstrated a statistically significant increase of urine pH as compared to placebo (P Discussion A stable urine pH over 24 hours with two doses per day was obtained for the majority of samples, despite a strong nyctohemeral rhythm. Conclusions ADV7103, proved its efficacy in maintaining a constant increase of the urine pH over 24 hours with 2 daily intakes. The safety profile has been confirmed. |
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