Pharmacokinetics, Bioequivalence, and Safety of 2 Formulations of Hydroxychloroquine Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions
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DOI: 10.1002/cpdd.1166
Abstract: The purpose of this trial was to evaluate the pharmacokinetics (PK), bioequivalence (BE), and safety of 2 preparations of hydroxychloroquine (200‐mg tablet) under fasting and fed conditions. A total of 180 subjects (fasting condition: n… read more here.
Keywords: safety; fasting fed; pharmacokinetics bioequivalence; fed conditions ... See more keywords
Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Formulations of 0.2‐g Ibuprofen Granules
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DOI: 10.1002/cpdd.1211
Abstract: Ibuprofen is a nonsteroidal anti‐inflammatory agent. In this study, we compared the pharmacokinetic properties, bioequivalence, and safety of a newly developed generic formulation (test) and a branded formulation (reference) of 0.2 g ibuprofen granules in… read more here.
Keywords: bioequivalence safety; ibuprofen granules; study; formulations ibuprofen ... See more keywords
Bioequivalence and safety evaluation of two preparations of metformin hydrochloride sustained-release tablets (Boke® and Glucophage®-XR) in healthy Chinese volunteers: a randomized phase I clinical trial
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DOI: 10.1080/07853890.2022.2125574
Abstract: Abstract Background As per the National Medical Products Administration (NMPA) requirements, the quality and efficacy of generic drugs must be consistent with those of the innovator drug. We aimed to evaluate the bioequivalence and safety… read more here.
Keywords: glucophage; bioequivalence; bioequivalence safety; healthy chinese ... See more keywords
A randomized, open-label, single-dose, two-cycle crossover study to evaluate the bioequivalence and safety of lenvatinib and Lenvima® in Chinese healthy subjects.
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DOI: 10.1080/13543784.2022.2067528
Abstract: BACKGROUND Lenvatinib is a tyrosine kinase receptor inhibitor that inhibits vascular and endothelial growth factor receptor kinase activity. This study evaluated the bioequivalence and safety of lenvatinib developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.… read more here.
Keywords: cycle; lenvatinib lenvima; study; bioequivalence safety ... See more keywords
A multicenter randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Caelyx ® in advanced breast cancer
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DOI: 10.3389/fonc.2022.1070001
Abstract: Purpose To compare the pharmacokinetic (PK) bioequivalence (BE) and safety of a generic pegylated liposomal doxorubicin (PLD) formulation with the reference product Caelyx®. Methods A multicenter, single-dose, open-label, randomized, two-way crossover study was conducted in… read more here.
Keywords: doxorubicin; encapsulated doxorubicin; bioequivalence; bioequivalence safety ... See more keywords