Prexxartan (valsartan oral solution) / Carmel Biosci - LARVOL DELTA

A Phase III Clinical Study of Valsartan Oral Solution for the Treatment of Hypertension in Children and Adolescents (clinicaltrials.gov) - P3 | N=342 | Enrolling by invitation | Sponsor: Shandong New Time Pharmaceutical Co., LTD

New P3 trial • Cardiovascular • Hypertension

Design, Formulation, and Characterization of Valsartan Nanoethosomes for Improving Their Bioavailability. (PubMed, Pharmaceutics) - "The prepared VLT ethosomal gel (VLT-ethogel) showed a high peak plasma concentration and enhanced bioavailability in rats compared with the oral solution of valsartan presented in the higher AUC (0-∞). The AUC (0-∞) with oral treatment was 7.0 ± 2.94 (μg.h/mL), but the AUC (0-∞) with topical application of the VAL nanoethosomal gel was 137.2 ± 49.88 (μg.h/mL), providing the sustained release pattern of VLT from the tested ethosomal gel."

Journal

The Bioequivalence Between Valsartan Oral Solution and Suspension Formulations Developed for Pediatric Use. (PubMed, Clin Pharmacol Drug Dev) - "Compared to suspension formulation, the mean peak plasma concentration with solution formulation was higher by 32% (90%CI, 1.27-1.38) while the geometric mean ratios (1.09) and the associated 90%CIs (1.05-1.13) of both the areas under the concentration time-curves (from time zero to the last quantifiable concentration and from time zero to infinity) were contained in the required range of 0.80 to 1.25. No new safety signals were observed with either of the formulations."

Clinical • Journal • Hypertension • Pediatrics