Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet.

Mohamed BadawiXin ChenPatrick MarroumAhmed A Suleiman Sven MensingAnette KoenigsdorferJulia Teresa SchieleTammy Palenski Divya SamineniDavid HoffmanRajeev M Menon Ahmed Hamed Salem

Published in: Clinical drug investigation (2022)

The smaller-sized tablets (10 and 50 mg) and the newly developed oral powder formulations of venetoclax can be used interchangeably with the 100 mg tablets to improve the patients' experience, while maintaining adequate exposure. CLINICAL TRIALS IDENTIFIERS: NCT01682616, 11 September 2012; NCT02005471, 9 December 2013; NCT02242942, 17 September 2014; NCT02203773, 30 July 2014; NCT02287233, 10 November 2014; NCT02993523, 15 December 2016; NCT03069352, 3 March 2017.

Keyphrases

clinical trial
end stage renal disease
newly diagnosed
ejection fraction
prognostic factors
randomized controlled trial
chronic lymphocytic leukemia
open label
phase iii