Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy Volunteers

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2014
The study will be conducted in adult healthy participants and will consist of two phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a Screening Period and a Baseline Period. The Randomization Phase will consist of 2 Periods (each 6 days long) separated by a 1-day long Baseline Period and End of Treatment (EOT) Period. A total of 60 participants will be enrolled into one of three arms. Arms 1 and 3 consist of 2 sequences, and Arm 2 consists of 4 sequences (as this is an incomplete block design with 2 factors \[number of capsules and whether water or apple juice is used as vehicle\]). Each participant will be randomized into one of 8 sequences.
Epistemonikos ID: 572e3702eaec352fba53ccac7556d7334a01ee30
First added on: May 17, 2024