Comparison Of Dsingle-Dose Pharmacokinetics Of Candesartan Cilexetil In Healthy Male & Female
By: Hafiz Awais Nawaz
| Muhammad Irfan Masood.
Contributor(s): Dr. Mateen | Dr. Sualeha Riffat.
Material type: 
BookPublisher: 2012Subject(s): Institute of Pharmaceutical Sciences ( IPS )DDC classification: 1442,T Dissertation note: This study was designed to compare the pharmacokinetic parameters of Candesartan in 8 healthy male and female volunteers. The study was conducted in eight healthy male volunteers and eight healthy female volunteers. Only those male volunteers were selected who aged between 18-30 years, not suffering from any disease. Female volunteers were also between age of 18-30 years, who were not pregnant and not suffering from any disease. Written consent was taken from them and they were informed about objectives of the study, frequency of blood sampling, and possible side effects of drug which they might face during the study. The male volunteers were considered as group A and healthy female volunteers were considered as group B. Both groups were administered Candesartan 16mg tablet orally to each individual. 5ml Blood samples were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 & 72 hr after the oral drug administration from vein through 5ml B.D syringe of 22guage needle. Plasma was separated by centrifugation at 5000 RPM and stored at -80ºC till analysis. Candesartan concentrations in plasma were measured by HPLC method. All pharmacokinetic parameters were calculated by entering plasma concentration-time data in software APO pharmacological analysis MW/PHARM version 3.02 by assuming bio-availability of Candesartan after oral administration as 1. Pharmacokinetic parameters of Candesartan in healthy male and female volunteers were compared. Data was analyzed by unpaired t-test and it was observed that there is significant difference in AUC of Candesartan in healthy male and female volunteers after oral administration without any effect in Cmax, Tmax, volume of distribution, absorption rate constant or elimination half life. In general, candesartan produced comparable results in healthy male and female volunteers so there is no need of any dose adjustment during therapy in both genders.
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Thesis
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UVAS Library Thesis Section | Veterinary Science | 1442,T (Browse shelf) | Available | 1442,T |
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This study was designed to compare the pharmacokinetic parameters of Candesartan in 8 healthy male and female volunteers. The study was conducted in eight healthy male volunteers and eight healthy female volunteers. Only those male volunteers were selected who aged between 18-30 years, not suffering from any disease. Female volunteers were also between age of 18-30 years, who were not pregnant and not suffering from any disease. Written consent was taken from them and they were informed about objectives of the study, frequency of blood sampling, and possible side effects of drug which they might face during the study. The male volunteers were considered as group A and healthy female volunteers were considered as group B. Both groups were administered Candesartan 16mg tablet orally to each individual. 5ml Blood samples were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 & 72 hr after the oral drug administration from vein through 5ml B.D syringe of 22guage needle. Plasma was separated by centrifugation at 5000 RPM and stored at -80ºC till analysis. Candesartan concentrations in plasma were measured by HPLC method. All pharmacokinetic parameters were calculated by entering plasma concentration-time data in software APO pharmacological analysis MW/PHARM version 3.02 by assuming bio-availability of Candesartan after oral administration as 1. Pharmacokinetic parameters of Candesartan in healthy male and female volunteers were compared. Data was analyzed by unpaired t-test and it was observed that there is significant difference in AUC of Candesartan in healthy male and female volunteers after oral administration without any effect in Cmax, Tmax, volume of distribution, absorption rate constant or elimination half life. In general, candesartan produced comparable results in healthy male and female volunteers so there is no need of any dose adjustment during therapy in both genders.
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