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H. Plasma (h + plasma)

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Medical Sciences	100%

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Oral vitamin E supplementation on oxidative stress, vitamin and antioxidant status in intensely exercised horses

EQUINE VETERINARY JOURNAL, Issue S36 2006
C. A. WILLIAMS
Summary Reasons for performing study: Vitamin E is the most commonly supplemented antioxidant in horses; however, previous research is not conclusive as to the recommended level for exercising horses. Objective: To evaluate the effects of 3 levels of vitamin E supplementation on oxidative stress and vitamin/antioxidant status in intensely exercised horses to determine the optimal level of vitamin E supplementation. Methods: Twelve unfit Standardbreds were divided into 3 groups, supplemented orally with 0 (CON), 5000 (MOD), or 10,000 (HI) iu/day of DL-,-tocopheryl acetate. The 3 times 3 Latin square design consisted of three 4 week supplementation periods with 4 week wash out periods between. After each period, horses underwent a treadmill interval exercise test. Blood samples were collected and heart rate (HR) measured before, during and after exercise. Data were analysed using ANOVA with repeated measures in SAS. Results: The CON group had lower HR throughout the test compared to the MOD and HI groups (P<0.05). There was an increase in plasma retinol (RET), ,-carotene (BC), red blood cell total glutathione and glutathione peroxidase with exercise (P<0.05), but all groups returned to baseline after 24 h. Plasma ,-tocopherol (TOC) increased from baseline with exercise (P<0.0001) in all groups; treatment differences were observed at 24 h (P<0.05). The HI and CON groups had lower BC compared to the MOD group (P = 0.05). Conclusions: Horses supplemented with vitamin E, at nearly 10-times the 1989 NRC recommended level, did not experience lower oxidative stress compared to control horses. Additionally, lower plasma BC levels observed in the HI group, which may indicate that vitamin E has an inhibitory effect on BC metabolism. Potential relevance: Supplementation above control levels is not more beneficial to oxidative stress and antioxidant status in intensely exercising horses; indeed, levels 10 times in excess may be detrimental to BC and should be avoided. [source]

Bioequivalence evaluation of two brands of ketoconazole tablets (Onofin-K® and Nizoral®) in a healthy female Mexican population

BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 5 2004
G. Marcelín-Jiménez
Abstract A randomized, crossover study was conducted in 24 healthy female volunteers to compare the bioavailability of two brands of ketoconazole (200 mg) tablets; Onofin-K® (Farmacéuticos Rayere S.A., México) as the test and NIZORAL® (Janssen-Cilag, México) as the reference products. The study was performed at the Clinical Pharmacology Research Center of the Hospital General de México in Mexico City. Two tablets (400 mg) were administered as a single dose with 250 ml of water after a 12 h overnight fast on two treatment days separated by a 1 week washout period. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested was analysed for ketoconazole by a modified and validated HPLC method with UV detection in the range 400,14000 ng/ml, using 200 µl of plasma in a full-run time of 2.5 min. The pharmacokinetic parameters AUC0,t, AUC0,,, Cmax, Tmax and t1/2 were determined from plasma concentrations of both formulations and the results discussed. AUC0,t, AUC0,, and Cmax were tested for bioequivalence after log transformation of data, and no significant differences were found either in 90% classic confidence interval or in the Anderson and Hauck test (p<0.05). Based on statistical analysis, it is concluded that Onofin-K® is bioequivalent to Nizoral®. Copyright © 2004 John Wiley & Sons, Ltd. [source]

Bioequivalence evaluation of two brands of furosemide 40mg tablets (Salurin and Lasix) in healthy human volunteers

BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 6 2003
Naji Najib
Abstract A randomized, two-way, crossover, bioequivalence study was conducted in 24 fasting, healthy, male volunteers to compare two brands of furosemide 40 mg tablets, Salurin (Julphar, UAE) as test and Lasix (Hoechst AG, Germany) as reference product. The study was performed at the International Pharmaceutical Research Centre (IPRC), in a joint venture with Al-Mowasah Hospital, Amman, Jordan. One tablet of either formulation was administered with 240 ml of water after a 10 h overnight fast. After dosing, serial blood samples were collected for a period of 12 h. Plasma harvested from blood was analysed for furosemide by a validated HPLC method. Various pharmacokinetic parameters including AUC0,t, AUC0,,, Cmax, Tmax, T1/2, and elimination rate constant were determined from plasma concentrations of both formulations. Statistical modules (ANOVA and 90% confidence intervals) were applied to AUC0,t, AUC0,,, and Cmax to assess the bioequivalence of the two brands which revealed no significant difference between them, and 90% CI fell within the US FDA accepted bioequivalence range of 80%,125%. Based on these statistical inferences, Salurin was found to be bioequivalent to Lasix. Copyright © 2003 John Wiley & Sons, Ltd. [source]

Bioequivalence assessment of Azomycin® (Julphar, UAE) as compared to Zithromax® (Pfizer, USA),two brands of azithromycin,in healthy human volunteers

BIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 1 2001
Naji M. Najib
Abstract Two studies have been performed to assess the relative bioavailability of Azomycin® (Julphar, UAE) as compared with Zithromax® (Pfizer, USA) at the International Pharmaceutical Research Center (IPRC), Amman, Jordan. One study involved Azomycin® capsules and the other Azomycin® suspension. Each study enrolled 24 volunteers and in both studies, after an overnight fasting, the two brands of azithromycin were administered as single dose on two treatment days separated by a 2 weeks washout period. After dosing, serial blood samples were collected for a period of 192 h. Plasma harvested from blood, was analysed for azithromycin by HPLC coupled with electrochemical detection. Various pharmacokinetic parameters including AUC0,t, AUC0,,,Cmax, Tmax, T1/2 and Kelm were determined from plasma concentrations for both formulations and found to be in good agreement with the reported values. AUC0,t, AUC0,, and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence intervals for the test/reference ratios of these parameters were found within the bioequivalence acceptance range of 80,125%. Based on these statistical inferences it was concluded that Azomycin® capsule is bioequivalent to Zithromax® capsule and Azomycin® suspension is bioequivalent to Zithromax® suspension. Copyright © 2001 John Wiley & Sons, Ltd. [source]