Clinical therapeutics
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Clinical therapeutics · Jul 2009
Randomized Controlled Trial Comparative StudyBioequivalence of two formulations of glucosamine sulfate 500-mg capsules in healthy male Chinese volunteers: an open-label, randomized-sequence, single-dose, fasting, two-way crossover study.
Glucosamine sulfate is used for the treatment of arthrosis, especially osteoarthritis of the knee joint. The available evidence suggests differences in its pharmacokinetics in Chinese subjects compared with non-Chinese subjects. ⋯ In this small study in healthy male Chinese volunteers, a single 500-mg dose of the test formulation met the SFDA's regulatory definition for bioequivalence to the reference formulation. Both formulations were well tolerated.
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Clinical therapeutics · Jul 2009
Randomized Controlled TrialBioequivalence of generic and branded subcutaneous enoxaparin: a single-dose, randomized-sequence, open-label, two-period crossover study in healthy Chinese male subjects.
Enoxaparin is a low-molecular-weight heparin (LMWH) indicated for antithrombosis. A branded formulation of subcutaneously administered enoxaparin has been available in China since 2000, and a generic formulation is being developed. In a literature search of the key term enoxaparin (publication years not restricted), no published data were identified regarding the pharmacokinetic profile of generic enoxaparin in Chinese subjects. ⋯ Based on the 90% CIs of anti-Xa and anti-IIa activities, heparin clotting assay results, and aPTT in these healthy Chinese male subjects, the test and reference formulations of enoxaparin 60 mg SC met the regulatory requirements for bio-equivalence. Both formulations were well tolerated.