Sivasubramanian, Rama, Sunkara, Gangadhar, Karan, Rajesh, Zhou, Wei, Zhang, Yiming and Sangana, Ramachandra (2022) The bioequivalence between pediatric-centric valsartan oral solution and extemporaneous suspension formulations. Clinical Pharmacology in Drug Development, 11 (7). pp. 843-848. ISSN 2160-763X2160-7648

Abstract

The bioequivalence of valsartan 160 mg oral solution compared to extemporaneous suspension was assessed in a single-dose, open-label, randomized, two-period, two-way crossover study in 82 healthy adults. The participants were randomized (1:1) to receive a single dose of the solution or suspension formulation in each of the two treatment periods. Serial blood samples for pharmacokinetic (PK) evaluation were collected up to 48 hours post-dose. The PK parameters were estimated by noncompartmental methods and analyzed as per bioequivalence criteria of statistical analysis. The peak plasma concentration (Cmax) of valsartan was reached with median time (Tmax) of 1 and 3 hours with solution and suspension formulation, respectively. Compared to suspension formulation, the mean Cmax 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 [AUC (0-t) and AUC (0-∞)] were contained in the required range of 0.80–1.25. No new safety signals were observed with either of the formulations.

Item Type:	Article
Date Deposited:	15 Oct 2024 00:45
Last Modified:	15 Oct 2024 00:45
URI:	https://oak.novartis.com/id/eprint/45956