DS demonstrated a difference in muscle stiffness in the GCM between children with spastic cerebral palsy and those without neurologic and musculoskeletal disabilities.
As inhibitors of organic cation transporters (OCTs), proton pump inhibitors (PPIs) may affect the plasma levels of metformin, an OCT substrate. We investigated the effects of two PPIs, pantoprazole and rabeprazole, on metformin pharmacokinetics and glucose levels in healthy subjects. In this open, randomized, six-sequence, three-period crossover study, 24 participants were administered metformin, either alone or in combination with pantoprazole or rabeprazole. The plasma concentrations of metformin and serum concentrations of glucose after a 75-g oral glucose tolerance test (OGTT) were determined. The area under the concentration-time curve (AUC) for metformin was 15% and 16% greater following coadministration with pantoprazole and rabeprazole, respectively.The maximum plasma metformin concentrations (C max ) also increased by 15% and 22%, respectively, compared with when it was administered without the PPIs. The percentage change in the AUC for glucose concentration versus time for metformin plus rabeprazole was significantly lower than that for metformin plus pantoprazole [geometric mean ratio: 0.96 (90% confidence interval: 0.92-0.99) and 0.77 (0.63-0.93), respectively]. There was no significant difference in the maximum glucose concentration. In conclusion, concomitant administration of PPIs with metformin significantly increased plasma metformin exposure, but the effects on glucose disposition were minor and varied depending on the PPI administered.
Because bioequivalence studies are performed using a crossover design, information on the intrasubject coefficient of variation (intra-CV) for pharmacokinetic measures is needed when determining the sample size. However, calculated intra-CVs based on bioequivalence results of identical generic drugs produce different estimates. In this study, we collected bioequivalence results using public resources from the Ministry of Food and Drug Safety (MFDS) and calculated the intraCVs of various generics. For the generics with multiple bioequivalence results, pooled intra-CVs were calculated. The estimated intra-CVs of 142 bioequivalence studies were 14.7±8.2% for AUC and 21.7±8.8% for C max . Intra-CVs of C max were larger than those of area under the concentrationtime curve (AUC) in 129 studies (90.8%). For the 26 generics with multiple bioequivalence results, the coefficients of variation of intra-CVs between identical generics (mean±sd (min ~ max)) were 38.0±24.4% (1.9 ~ 105.3%) for AUC and 27.9±18.2% (4.0 ~ 70.1%) for C max . These results suggest that substantial variation exists among the bioequivalence results of identical generics. In this study, we presented the intra-CVs of various generics with their pooled intra-CVs. The estimated intraCVs calculated in this study will provide useful information for planning future bioequivalence studies. (This is republication of the article 'Transl Clin Pharmacol 2017;25:179-182
Levofloxacin is a bactericidal broad spectrum antibiotic against Gram-positive and Gram-negative pathogens. A randomized, two-treatment, two-period, two-way crossover study was conducted to evaluate the bioequivalence of Lectacin 250 mg tablet, a generic levofloxacin, to its reference drug, Cravit 250 mg tablet. Each period was separated by a 7-day washout. Serial blood samples were collected until 24 h after dosing and plasma levofloxacin concentrations were determined using a high performance liquid chromatography. Pharmacokinetic parameters were analyzed using K-BE Test 2007 and BA calc 2007 (Ministry of Food and Drug Safety, Cheongju-si, South Korea). The peak concentration (C max ) and the area under the plasma concentration versus time curve from 0 to the last measurable concentration (AUC 0-t ) for the generic and reference levofloxacin were 4.48±0.89 mg/L and 4.46± 0.95 mg/L, and 25.33±4.12 mg*h/L and 25.77±4.01 mg*h/L, respectively, leading to a geometric mean ratio (90% confidence interval) of the generic to the reference levofloxacin of 1.0060 (0.9339-1.0842) and 0.9810 (0.9476-1.0159), respectively, for C max and AUC 0-t . Lectacin 250 mg tablet is bioequivalent to Cravit 250 mg tablet. IntroductionLevofloxacin is the active S-enantiomer (L-isomer) of the racemic drug ofloxacin, an oral fluoroquinolone antimicrobial agent, and is approximately two times as potent as ofloxacin.[1] Levofloxacin possesses a broad spectrum of bactericidal activity against Gram-positive and Gram-negative pathogens such as Chlamydia, Legionella and Mycobacterium, which has made levofloxacin effective for the treatment of infectious diseases such as community-acquired pneumonia and acute exacerbation of chronic bronchitis. [2][3][4][5] In South Korea, levofloxacin has been approved to treat uncomplicated or complicated urinary tract infection, chronic bacterial prostatitis, community-acquired pneumonia, nosocomial pneumonia, and skin and/or subcutaneous tissue infections. For these indications, a daily dose of levofloxacin between 250 mg and 750 mg can be used. Among the dose strengths approved in South Korea, 250 mg is the most frequently used one given the dosage recommendations. UNIMED Pharm Inc. (Seoul, South Korea) has developed a new formulation of levofloxacin, Lectacin 250 mg tablet, containing the same amount of active ingredient and excipients as the reference levofloxacin drug, Cravit 250 mg tablet (Jeil Pharmaceutical Co. Ltd., Seoul, South Korea), which was approved by the Ministry of Food and Drug Safety (MFDS) for the indications mentioned above.The aim of the present study was to compare the pharmacokinetic profile of Lectacin 250 mg tablet (test drug) with that of Cravit 250 mg tablet (reference drug) and to assess the bioequivalence of the two formulations. MethodsThis study was conducted at the Clinical Trials Center (CTC), Kyung Hee University Hospital (KHUH), Seoul, South Korea. ORIGINAL ARTICLE Study productsThe test and reference drugs were Lectacin 250 mg tablet (batch number 08001, manufacture by ...
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