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Comparative Pharmacokinetics Of Carvediolol In Healty Male And Female Volunteers

By: Alishba syed | Dr. Sualeha Riuffat.
Contributor(s): Prof. Dr. Muhammad Ashraf.
Material type: materialTypeLabelBookPublisher: 2010Subject(s): Department of Pharmaoclogy & ToxicologyDDC classification: 1180,T Dissertation note: This study was designed to compare the pharmacokinetic parameters of Carvedilol in 6 healthy male and female volunteers. The study was conducted in six healthy male volunteers and six healthy female volunteers. Only those male volunteers were selected who were of age 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 be 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 treated with Carvedilol 12.5mg tablet per orally to each individual. 5m1 Blood samples were collected at 0, 0.25, 0.5, 1, 1.5. 2, 3, 4, 6, 8, 12 & 24 hr from vein through 5ml B.D syringe of 22guage needle after oral administration of Carvedilol. Plasma was separated by centrifugation at 5000 RPM and stored at -40°C till analysis. Carvedilol 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. Pharmacokinetic parameters of Carvedilol in healthy male volunteers and in healthy female volunteers were compared. Data was analyzed byapproprite statistical methods and no significant difference was found between AUC and Cmax. Absorption rate was highr in females as compared to males. AUC of Carvedilol was 0.076±0.021 µg.h/ml in healty male voluneteers and 0.197±0.105 µg.h/ml in healty female volunteers. The half life was 5.205±1.824 hours in healty male volunteers and 6.6768±1.328 hours in female volunteers. The Cmax was observed as 0.024±0.004 µg.h/ml in healty volunteers and 0.048±0.018 µg.h/ml in healty female volunteers.
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This study was designed to compare the pharmacokinetic parameters of Carvedilol in 6 healthy male and female volunteers. The study was conducted in six healthy male volunteers and six healthy female volunteers. Only those male volunteers were selected who were of age 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 be 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 treated with Carvedilol 12.5mg tablet per orally to each individual. 5m1 Blood samples were collected at 0, 0.25, 0.5, 1, 1.5. 2, 3, 4, 6, 8, 12 & 24 hr from vein through 5ml B.D syringe of 22guage needle after oral administration of Carvedilol. Plasma was separated by centrifugation at 5000 RPM and stored at -40°C till analysis. Carvedilol 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. Pharmacokinetic parameters of Carvedilol in healthy male volunteers and in healthy female volunteers were compared. Data was analyzed byapproprite statistical methods and no significant difference was found between AUC and Cmax. Absorption rate was highr in females as compared to males. AUC of Carvedilol was 0.076±0.021 µg.h/ml in healty male voluneteers and 0.197±0.105 µg.h/ml in healty female volunteers. The half life was 5.205±1.824 hours in healty male volunteers and 6.6768±1.328 hours in female volunteers. The Cmax was observed as 0.024±0.004 µg.h/ml in healty volunteers and 0.048±0.018 µg.h/ml in healty female volunteers.

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