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Lucia Rat Handayani
Department of Biotechnology, Atma Jaya Catholic University of Indonesia, Banten, Indonesia
Publications
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Research Article
Bioequivalence Study of Dapagliflozin 10 mg Film Coated Tablets in Healthy Indonesian Subjects under Fasting Condition
Author(s): Raymond R. Tjandrawinata*, Lucia Rat Handayani, Danang Agung Yunaidi, Vicky Achmad Ginanjar, Liana W. Susanto and Clarasintha Nindyatami
Purpose: This study aimed to demonstrate the bioequivalence of the Dapagliflozin 10 mg film-coated tablets manufactured by PT Dexa Medica, Indonesia, in comparison with the reference formulation, Forxiga® 10 mg filmcoated tablets, manufactured by AstraZeneca Pharmaceuticals. Patients and methods: This was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fasting conditions with a 5-day washout period. 24 enrolled healthy subjects, 22 subjects completed the study. The test or reference formulation was administered orally to the subjects in a randomized manner. A validated Ultra-Performance Liquid Chromatography with Tandem Mass Spectrometry (UPLC-MS/MS) detection method was used to assay the plasma concentration of Dapagliflozin. This study assessed the following pharmacokinetic par.. View more»