Bioequivalence Study Of Deferiprone In Healthy Volunteers (Record no. 3043)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 03016nam a2200181Ia 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20151005140905.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 150525s2011 xx 000 0 und d |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | eng |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 1327,T |
| 100 ## - MAIN ENTRY--AUTHOR NAME | |
| Personal name | Naila Waheed |
| 110 ## - MAIN ENTRY--CORPORATE NAME | |
| Location of meeting | Dr. Sualeha Riffat |
| 245 ## - TITLE STATEMENT | |
| Title | Bioequivalence Study Of Deferiprone In Healthy Volunteers |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Year of publication | 2011 |
| 502 ## - DISSERTATION NOTE | |
| Dissertation note | The study was conducted with the aim of evaluating bioequivalence, relative silability and efficacy of deferiprone manufactured locally (Ferinil, Global aceutical, Pakistan) with a reference drug (Ferriprox, ApoPharma, Canada) in healthy volunteers. It was a randomized crossover study enrolling 12 volunteers within age limit g·55yrs and meeting the inclusion and exclusion criteria of the study, Each volunteer was administered two tablets of deferiprone 500mg of both reference and test drug with a two- washout period. Blood samples of about 5ml was collected at 0, 0.25, 0.5, 0.75, 1, 1.5, 5,4, 6, 8, 12 hour at predetermined time intervals and one sample was taken as control giving first dose to volunteers. Heparinized vacuette was used for collection of blood les. After sampling, blood samples was centrifuged at approximately 3000 rpm for 10 les and then stored at -80°C till analyzed. Plasma deferiprone levels were analyzed using led High pressure liquid chromatography (HPLC) method. Pharmacokinetic parameters calculated from plasma concentration time curve non-compartmentally and two- artmental. After logarithmic transformation of data statistical comparisons of Cmax, (0-1), AUC(o.oo) was calculated and appropriate statistical method was used for calculation. mean relative bioavailability was 104% and was proved to be bioavailable. The Cmax (mean ±SD) for reference and test drug was 12.68 ± 4.91 and 14.41 ± 5.04 ug/ml, ctively while average ± SD of AUCO-t and AUCO-inf of test and reference drug was 40.49 6,05 and 42.84 ± 18.47 ugh/ml and 38.63 ± 13.65 and 40.75 ± 14.17 ugh/ml. Average (test/reference) of Cmax 90% CI was 0.9876-1.3125. Average ratio (test/reference) of Co.190% CI was 0.9737-1.1150, and of AUCo-inf 90% CI was 0.9542-1.1343. Therefore both test and reference drug was fairly tolerated by volunteers and no adverse event was detected. Hence, the average ratio of 90% confidence interval of AUCo-t and AUCO-inf was 0.9737-1.1150 and 0.9542-1.1343 that lie within the acceptable limit of (0.80 - 1.25) for bioequivalence acceptance. Effectiveness of deferiprone depends on AUC instead of Cmax therefore the average ratio of 90% confidence interval of Cmax was 0.9876-1.3125 that lie with the acceptable limit of WHO bioequivalence acceptance (0.75 - 1.33). ANOVA show no significant variations among drug, period and sequence effect. Therefore, it was concluded that Ferriprox was proved to be bioequivalent in healthy male Pakistani volunleers. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical Term | Department of Pharmaoclogy & Toxicology |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Prof. Dr. Muhammad Ashraf |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Koha item type | Thesis |
| Damaged status | Collection code | Permanent Location | Current Location | Shelving location | Date acquired | Full call number | Accession Number | Koha item type |
|---|---|---|---|---|---|---|---|---|
| Veterinary Science | UVAS Library | UVAS Library | Thesis Section | 2015-05-29 | 1327,T | 1327,T | Thesis |