A randomized, two-way, crossover study was conducted in 12 fasting, healthy, algerian volunteers to compare the bioavailability of two brands of metformin hydrochloride 850 mg coated tablets. The present study aimed t...A randomized, two-way, crossover study was conducted in 12 fasting, healthy, algerian volunteers to compare the bioavailability of two brands of metformin hydrochloride 850 mg coated tablets. The present study aimed to appreciate the bioequivalence of the generic product and to evaluate the intra-subject variability of this active substance in the Algerian population. The test brand was compared to Glucophage （Merck UK） as the reference product. The study was performed at the bioequivalence center of the national control laboratory for pharmaceuticals products from 03 to 04, 2011, in joint venture with specialized medical hospital center of E1 Hadi Flici, Algiers, Algeria. The drug was administered with 200 mL of water after a 10 h overnight fasting on two treatment days separated by one week washout period. After dosing, serial blood samples were collected for a period of 12 h. A reliable, simple, and robust liquid chromatography-tandem mass spectro-metric （LC-MS/MS） method has been developed and validated for estimation of metformin in human plasma using propranolol as internal standard. The analytes were extracted from plasma by using the protein precipitation extraction technique. The assay was found to be linear over the range of 50-3000 ng/mL with a lower limit of quantitation of 50 ng/mL. Various pharmacokinetic parameters including AUC0-t, AUC0-∞, Cmax, Tmax, and T1/2 were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. The pharmacokinetical and statistical analysis was conducted with Kinetica 4.4.1. AUC0-t, AUC0-∞ and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval （[91.62 %, 115.66%] for AUC0-t, [92.07 %, 115.53 %] for AUC0-∞; [94.58%, 119.58 %] for Cmax） of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80-125%. Based on these statistical inferences, it was concluded that Metformin hydrochloride test is bioequivalent to Glucophage.展开更多
A randomized, two-way, crossover study was conducted in 15 fasting, healthy, Algerian volunteers to compare the bioavailability of two brands of Valsartan 80 mg coated breakable tablets. The present study aimed to eva...A randomized, two-way, crossover study was conducted in 15 fasting, healthy, Algerian volunteers to compare the bioavailability of two brands of Valsartan 80 mg coated breakable tablets. The present study aimed to evaluate the intra-subject variability of this active substance in the Algerian population. The test brand was compared to TAREG （Novartis） as the reference product. The study was performed at the bioequivalence center of the national control laboratory for pharmaceuticals products, in joint venture with University Hospital Center Ibn Badis, Constantine, Algeria. The drug was administered with 200 mL of water after a 10 h overnight fasting on two treatment days separated by one week washout period. After dosing, serial blood samples were collected for a period of 24 h. A reliable, simple, and robust liquid chromatography-tandem mass spectro-metric （LC-MS/MS） method has been developed and validated that employs protein precipitation （or denaturation） for the estimation of valsartan in human plasma using losartan as internal standard. The assay was found to be linear over the range of 50-5,000 ng/mL, with a lower limit of quantitation of 50ng/mL. Various pharnaacokinetic parameters including AUC0-t, AUC∞, Cmax, Tmax, and TI/2 were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. The pharmacokinetical and statistical analysis was conducted with Kinetica 4.4.1. AUC0.t, AUC0-∞ and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval （[85.82%, 118.76%] for AUC0.t [86.09%, 118.83%] for AUC0-∞） of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80-125%. But for the Cmax, the 90% confidence interval of test/reference ratio wasn＇t in this acceptance range [90.18%, 131.07%] .The results of PK analysis suggested that the reference and test formulations ofvalsartan 80 mg coated breakable tablets weren＇t bioequivalent during fasting state in these healthy algerian volunteers.展开更多
The 10 ASEAN CAssociation of Southeast Asian Nations） countries in Southeast Asia have been united for ASEAN community in 2015. Thailand is one of the members who take health and wellness tourism responsibility about...The 10 ASEAN CAssociation of Southeast Asian Nations） countries in Southeast Asia have been united for ASEAN community in 2015. Thailand is one of the members who take health and wellness tourism responsibility about tourism and product information, and health and wellness tourism standardization. Therefore, the researcher has studied in health tourism image in Thailand and ASEAN, because the image is significant cost to promote health and wellness tourism. They are factors that influence image management and also image attributes about health and wellness tourism in Thailand and ASEAN countries. In this study, the author aimed at the examination of influenced factors and the attributes for Thailand＇s and ASEAN＇s images of health and wellness tourism management and finding out the relations among cognitive, affective, and brand engagement in Thailand and ASEAN. This research could be used as guideline information for creation of plans and governmental policies of health and wellness tourism of Thailand and ASEAN region as well. The data obtained in this study included overall image and destination brand engagement, or personal engagement through way of life and daily life of Southeast Asian people. Southeast Asia has its uniqueness according to its slogan ASEAN Southeast Asia： Feel the Warmth. This is considered as one of unique activities in health and wellness tourism. Tourists can have their direct experiences with unique tradition of each nation.展开更多
文摘A randomized, two-way, crossover study was conducted in 12 fasting, healthy, algerian volunteers to compare the bioavailability of two brands of metformin hydrochloride 850 mg coated tablets. The present study aimed to appreciate the bioequivalence of the generic product and to evaluate the intra-subject variability of this active substance in the Algerian population. The test brand was compared to Glucophage （Merck UK） as the reference product. The study was performed at the bioequivalence center of the national control laboratory for pharmaceuticals products from 03 to 04, 2011, in joint venture with specialized medical hospital center of E1 Hadi Flici, Algiers, Algeria. The drug was administered with 200 mL of water after a 10 h overnight fasting on two treatment days separated by one week washout period. After dosing, serial blood samples were collected for a period of 12 h. A reliable, simple, and robust liquid chromatography-tandem mass spectro-metric （LC-MS/MS） method has been developed and validated for estimation of metformin in human plasma using propranolol as internal standard. The analytes were extracted from plasma by using the protein precipitation extraction technique. The assay was found to be linear over the range of 50-3000 ng/mL with a lower limit of quantitation of 50 ng/mL. Various pharmacokinetic parameters including AUC0-t, AUC0-∞, Cmax, Tmax, and T1/2 were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. The pharmacokinetical and statistical analysis was conducted with Kinetica 4.4.1. AUC0-t, AUC0-∞ and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval （[91.62 %, 115.66%] for AUC0-t, [92.07 %, 115.53 %] for AUC0-∞; [94.58%, 119.58 %] for Cmax） of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80-125%. Based on these statistical inferences, it was concluded that Metformin hydrochloride test is bioequivalent to Glucophage.
文摘A randomized, two-way, crossover study was conducted in 15 fasting, healthy, Algerian volunteers to compare the bioavailability of two brands of Valsartan 80 mg coated breakable tablets. The present study aimed to evaluate the intra-subject variability of this active substance in the Algerian population. The test brand was compared to TAREG （Novartis） as the reference product. The study was performed at the bioequivalence center of the national control laboratory for pharmaceuticals products, in joint venture with University Hospital Center Ibn Badis, Constantine, Algeria. The drug was administered with 200 mL of water after a 10 h overnight fasting on two treatment days separated by one week washout period. After dosing, serial blood samples were collected for a period of 24 h. A reliable, simple, and robust liquid chromatography-tandem mass spectro-metric （LC-MS/MS） method has been developed and validated that employs protein precipitation （or denaturation） for the estimation of valsartan in human plasma using losartan as internal standard. The assay was found to be linear over the range of 50-5,000 ng/mL, with a lower limit of quantitation of 50ng/mL. Various pharnaacokinetic parameters including AUC0-t, AUC∞, Cmax, Tmax, and TI/2 were determined from plasma concentrations of both formulations and found to be in good agreement with reported values. The pharmacokinetical and statistical analysis was conducted with Kinetica 4.4.1. AUC0.t, AUC0-∞ and Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on ANOVA; 90% confidence interval （[85.82%, 118.76%] for AUC0.t [86.09%, 118.83%] for AUC0-∞） of test/reference ratio for these parameters were found within bioequivalence acceptance range of 80-125%. But for the Cmax, the 90% confidence interval of test/reference ratio wasn＇t in this acceptance range [90.18%, 131.07%] .The results of PK analysis suggested that the reference and test formulations ofvalsartan 80 mg coated breakable tablets weren＇t bioequivalent during fasting state in these healthy algerian volunteers.
文摘The 10 ASEAN CAssociation of Southeast Asian Nations） countries in Southeast Asia have been united for ASEAN community in 2015. Thailand is one of the members who take health and wellness tourism responsibility about tourism and product information, and health and wellness tourism standardization. Therefore, the researcher has studied in health tourism image in Thailand and ASEAN, because the image is significant cost to promote health and wellness tourism. They are factors that influence image management and also image attributes about health and wellness tourism in Thailand and ASEAN countries. In this study, the author aimed at the examination of influenced factors and the attributes for Thailand＇s and ASEAN＇s images of health and wellness tourism management and finding out the relations among cognitive, affective, and brand engagement in Thailand and ASEAN. This research could be used as guideline information for creation of plans and governmental policies of health and wellness tourism of Thailand and ASEAN region as well. The data obtained in this study included overall image and destination brand engagement, or personal engagement through way of life and daily life of Southeast Asian people. Southeast Asia has its uniqueness according to its slogan ASEAN Southeast Asia： Feel the Warmth. This is considered as one of unique activities in health and wellness tourism. Tourists can have their direct experiences with unique tradition of each nation.
