Clinical therapeutics
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Clinical therapeutics · Oct 2009
Randomized Controlled Trial Multicenter StudyDiclofenac potassium liquid-filled soft gelatin capsules in the management of patients with postbunionectomy pain: a Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted over 5 days.
Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is a rapidly absorbed formulation of diclofenac potassium developed for the treatment of mild to moderate acute pain. ⋯ DPSGC 25 mg taken every 6 hours was effective in reducing postbunionectomy pain in the patients studied. DPSGC was well tolerated, suggesting that it may be a practicable option for the treatment of mild to moderate acute pain. ClinicalTrials. gov identifier: NCT00366444.
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Clinical therapeutics · Oct 2009
Randomized Controlled Trial Comparative StudyA comparison of pretreatment with fentanyl and lidocaine preceded by venous occlusion for reducing pain on injection of propofol: a prospective, randomized, double-blind, placebo-controlled study in adult Japanese surgical patients.
Pain on injection is a recognized adverse effect of propofol, an agent used to induce general anesthesia in surgical patients. Pretreatment with fentanyl has been reported to be effective in reducing propofol-induced pain. ⋯ Preceded by venous occlusion for 1 minute, fentanyl 100 microg was not significantly different from lidocaine 40 mg in reducing pain during injection of propofol in these adult Japanese surgical patients. Fentanyl 50 microg was ineffective in reducing such pain compared with placebo.
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Clinical therapeutics · Oct 2009
Randomized Controlled Trial Comparative StudyBioequivalence of a single 10-mg dose of finasteride 5-mg oral disintegrating tablets and standard tablets in healthy adult male Han Chinese volunteers: a randomized sequence, open-label, two-way crossover study.
Finasteride, an inhibitor of the steroid 5alpha-reductase, has been approved for the treatment of benign prostatic hyperplasia and androgenetic alopecia. An orally disintegrating tablet (ODT) 5-mg formulation of finasteride was recently developed. Information regarding its pharmacokinetics and bioequivalence was required to assess the efficacy and safety of this formulation before marketing it in China. ⋯ In this single-dose study, based on the rate and extent of absorption, the ODT (ie, test) and standard tablet (ie, reference) formulations of finasteride met the regulatory criteria for bioequivalence in these fasting healthy adult male Han Chinese volunteers. However, a significant difference was found for T(max) between the test and reference formulations. Both formulations were well tolerated. ClinicalTrials. gov identifier: 2005L02216.
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Clinical therapeutics · Oct 2009
Randomized Controlled Trial Comparative StudyComparison of the pharmacokinetics of ticlopidine between administration of a combined fixed-dose tablet formulation of ticlopidine 250 mg/ginkgo extract 80 mg, and concomitant administration of ticlopidine 250-mg and ginkgo extract 80-mg tablets: an open-label, two-treatment, single-dose, randomized-sequence crossover study in healthy Korean male volunteers.
Ticlopidine is an antiplatelet agent used for the prevention of vascular accidents. In clinical practice in Korea, ginkgo extract may be administered along with ticlopidine to enhance the inhibition of platelet aggregation. ⋯ Administration of a single dose of a combined fixed-dose formulation of ticlopidine 250 mg/ ginkgo extract 80-mg tablets and concomitant administration of ticlopidine and ginkgo extract tablets did not result in statistically significant differences in the pharmacokinetics of ticlopidine in these healthy Korean male volunteers.
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Clinical therapeutics · Oct 2009
Randomized Controlled TrialEffects of food intake on the pharmacokinetics of diclofenac potassium soft gelatin capsules: a single-dose, randomized, two-way crossover study.
Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is an investigational formulation that uses dispersing agents designed to facilitate rapid and consistent absorption of this NSAID. ⋯ Food intake did not appear to affect the extent of absorption (ie, total exposure) of oral DPSGC at doses of 25 and 50 mg in these healthy adult volunteers. Both single doses appeared to be well tolerated.