Clinical therapeutics
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Clinical therapeutics · Oct 2008
Randomized Controlled TrialAssessment of the bioequivalence of two formulations of clarithromycin extended-release 500-mg tablets under fasting and fed conditions: a single-dose, randomized, open-label, two-period, two-way crossover study in healthy Jordanian male volunteers.
Clarithromycin extended-release tablets are indicated for the treatment of adults with acute maxillary sinusitis caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae; acute bacterial exacerbation of chronic bronchitis due to H influenzae, Haemophilus parainfluenzae, M catarrhalis, or S pneumoniae; or community acquired pneumonia due to H influenzae, H parainfluenzae, M catarrhalis, S pneumoniae, Chlamydia pneumoniae, or Mycoplasma pneumoniae. ⋯ In these fasting and fed studies in healthy male Jordanian volunteers, the 2 formulations of clarithromycin extended-release 500-mg tablets were found to be bioequivalent according to the US Food and Drug Administration regulatory definition. Administration with food significantly increased the rate and extent of absorption of both products, with no significant effect on their bioequivalence.
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Clinical therapeutics · Sep 2008
ReviewIxabepilone: a novel microtubule inhibitor for the treatment of locally advanced or metastatic breast cancer.
Ixabepilone is the first member of the epothilones, a new class of anticancer drugs. It is approved for use as monotherapy in patients with locally advanced or metastatic breast cancer that has failed to respond to therapy with a taxane, an anthracycline, and capecitabine, or in combination with capecitabine in patients with locally advanced or metastatic breast cancer that has failed to respond to therapy with a taxane and an anthracycline. ⋯ Ixabepilone, a new antineoplastic agent with antimitotic capabilities, is approved for use with or without capecitabine in the management of metastatic or locally advanced breast cancer. It has also been evaluated for antitumor activity in a number of other cancers. The potential for significant toxicity with ixabepilone requires close clinical observation to assess the need for dose adjustment.
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Clinical therapeutics · Sep 2008
Randomized Controlled Trial Comparative StudyBioequivalence and pharmacokinetic comparison of a single 200-mg dose of meclofenoxate hydrochloride capsule and tablet formulations in healthy Chinese adult male volunteers: a randomized sequence, open-label, two-period crossover study.
Meclofenoxate hydrochloride is a psychostimulant in the nootropic agent group available in capsule and tablet formulations approved for traumatic cataphora, alcoholic poisoning, anoxia neonatorum, and children's enuresis in China. Although these 2 generic formulations are marketed in China, information regarding their pharmacokinetics and bioequivalence in humans has not been published. ⋯ In this small study in healthy Chinese adult male volunteers, a single 200-mg dose of the capsule formulation was found to be bioequivalent to a single 200-mg dose of the tablet formulation based on the US FDA's regulatory definition (rate and extent of absorption). Both formulations were well tolerated.
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Clinical therapeutics · Sep 2008
Compliance with antithrombotic prescribing guidelines for patients with atrial fibrillation--a nationwide descriptive study in Taiwan.
This study examined compliance with prescribing guidelines for antithrombotic therapy in patients with atrial fibrillation (AF) in Taiwan, using the 2001 joint guideline from the American College of Cardiology, American Heart Association, and European Society of Cardiology. The study also sought to identify factors associated with the appropriate prescribing of antithrombotic therapy. ⋯ Most of these patients with AF in Taiwan did not receive appropriate antithrombotic therapy over the period studied. Bleeding risk factors, hypertension, coronary artery disease, thyrotoxicosis, and older age were associated with low rates of warfarin use.