Bioequivalence Study Of Montelukast Tablets In Healthy Volunteets (Record no. 3027)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02504nam a2200181Ia 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20151005140011.0 |
| 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 | 1311,T |
| 100 ## - MAIN ENTRY--AUTHOR NAME | |
| Personal name | Sadia Amin |
| 110 ## - MAIN ENTRY--CORPORATE NAME | |
| Location of meeting | Dr. Sualeha Riffat |
| 245 ## - TITLE STATEMENT | |
| Title | Bioequivalence Study Of Montelukast Tablets In Healthy Volunteets |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Year of publication | 2011 |
| 502 ## - DISSERTATION NOTE | |
| Dissertation note | Objective of this bioequivalence study was to compare pharmacokinetic parameters and to evaluate bioequivalence of two generic drug products. A multinational company brand was compared with locally manufacture brand. It was a randomized, single dose, two-period crossover study in which 12 volunteers were participated with the age limit of 18-30yrs. These volunteers were selected according to different inclusion and exclusion criteria and the study was conducted with one week washout period. Each volunteer was one tablet of montelukast (reference or test) lOmg. 14 blood samples of 4-Sml collected at predefined time intervals i.e, 0, O.S, 1.0, 1.S, 2.0, 2.5, 3.0, 3.S, 4.0, 6.0, 8.0, 10, 12 and 24 hours .. Heparinized vacuette were used for collection of blood samples. After sampling, blood samples were centrifuged immediately to separate plasma and stored at -80°C till analyzed. Plasma montelukast concentration was evaluated by using reverse phase - high performance liquid chromatography (RP-HPLC) method. Potassium dihydrogen phosphate O.OSM at pH 3.5 with orthophosphoric acid in combination to acetonitrile (20:80) was used as mobile phase. The wavelength of detector was set at 34Snm and flow rate was set to 2.0ml per min. Drug from plasma was extracted by de-proteinizing the plasma with acetonitrile. 70 III injection volume was given to HPLC for analysis. For comparing the pharmacokinetic parameters two compartment analysis was used and pair t-test was applied. Non compartmental analysis was used for evaluating pharmacokinetic parameters to evaluate the both drugs were bioequivalent or not. 3 major parameters of bioequivalence Cmax, AVC O-inf and AVC O-t were evaluated and they did not show significant difference in between two formulations. Also the 90% confidence interval values were within the limit. So, it was concluded that both the test and reference drug were bioequivalent and test drug could be used interchangeably with the reference drug. |
| 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 | 1311,T | 1311,T | Thesis |