Evaluation of the bioequivalence and food effect on the bioavailability of CC-486 (oral azacitidine) tablets in adult patients with cancer.

ABSTRACT:

Purpose

CC-486 is an oral formulation of azacitidine that allows for extended dosing schedules to prolong azacitidine exposure to malignant cells and maximize clinical activity. CC-486 300 mg daily, administered for 14 or 21 days of 28-day treatment cycles, is currently under investigation in two ongoing phase III trials. The 300-mg daily dose in these studies is administered as two 150-mg tablets (Formulation A).

Methods

We evaluated the bioequivalence of one 300-mg CC-486 tablet (Formulation B) with Formulation A and food effect on Formulation B, in adult patients with cancer in a 2-stage crossover design study.

Results

The ratios of the geometric means of the maximum azacitidine plasma concentration (C_max) and of the area under the plasma concentration-t

SUBMITTER: Babiker HM 

PROVIDER: S-EPMC7036073 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature