Journal of Bioequivalence & Bioavailability

Dexa Laboratories of Biomolecular Sciences, Cikarang, West Java, Indonesia

Publications

• Research Article   
  Pharmacokinetic Equivalence Study of the Oral Direct Inhibitor of Factor Xa Anticoagulant, Rivaroxaban Film-Coated Tablets, in Healthy Subjects Under Fasting and Fed Conditions
  Author(s): Raymond R. Tjandrawinata*, Danang Agung Yunaidi, Yantirta Indra Kurniawan, Clarasintha Nindyatami, Ismail Dwi Saputro, Ima Aisyah Rahma, Vicky Achmad Ginanjar and Liana W. Susanto
  
  Purpose: To evaluate the bioequivalence of two strengths of Rivaroxaban 10 mg and 20 mg film-coated tablets manufactured by PT Dexa Medica with the reference drug, Xarelto® film-coated tablet, manufactured by Bayer AG, Germany, imported by PT Bayer Indonesia, Indonesia. Materials and Methods: Two studies were conducted separately under fasting condition for the 10 mg strength and fed condition for the 20 mg. The studies were open-label, randomized, single-dose, two-period, two-sequence, two-way crossover studies, which included 28 healthy adult male and female subjects in each study. The washout period was five days and 11 days for the 10 mg strength and 20 mg, respectively. The 10 mg study was completed by 28 subjects, whereas the 20 mg strength study was completed by 26 subjects. The plasma concentrations of Rivaroxaban were.. View more»
  

  DOI: 10.35248/0975-0851.24.16.595

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