Italini, Jamatia (2016) An Open Label Two Way Two Period Randomised Single Dose Comparitive Oral Bioavailability study of Zafirlukast in Healthy Volunteers Under Fasting Conditions. Masters thesis, C. L. Baid Metha College of Pharmacy, Chennai.
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Abstract
INTRODUCTION: Generic drugs are cost effective alternatives for the brand name drugs and the savings are estimated in the average $8 to $10 billion a year. (Lauren et al., 2009; Information for Consumers). Over the years the prescription of generic drugs has increased substantially (1984: 19% & 2009- 60-70%) (IMS health; Information for consumers). Bioequivalence testing is playing a vital role in generic drug development. The generics have to be developed and tested in human subjects by following stringent GCP/GLP standards. From industry point of view, there is a need to conduct bioequivalence studies at an allowable cost to have an effective generic development program in a scientifically acceptable standard. In order to achieve this from time to time various regulatory agencies have issued guidance’s to bring more clarity and uniformity for conducting Bioavailability (BA)/ Bioequivalence (BE) studies.STUDY OBJECTIVES:The basic aim of this project was to study the conductance of BE study, in accordance with the regulatory guidelines. The BE study was conducted on a test product, Zafirlukast and a reference product singuliar. The study objectives included: i. Assessment of the bioavailability of test product A while comparing with a reference product B in 12 healthy, normal, adult, human subjects under fasting conditions. ii. Investigate the source of the observed variability in the Cmax of Test drug.CONCLUSION:All the study procedures followed were in compliance with the protocol and the ICH- GCP guidelines, Declaration of Helsinki and Schedule Y. From the results obtained, in both the fast and the fed study, it is observed that there is no significant difference in the pharmacokinetic parameters, indicating that the bioavailability of drug XY is not affected by food. From the analyses of pharmacokinetic and statistical results it was inferred that, for the ln- transformed data, the 90 % confidence interval about the test to reference ratio of Cmax, AUC0-t and AUC0- of drug XY were falling within the bioequivalence acceptance range of 80.00 % - 125.00 %, which demonstrates the bioequivalence of test formulation ‘ZAFIRLUKAST’ with reference formulation ‘SINGULIAR’ under fasting conditions. From the clinical data it can be concluded that the study objectives like the safety and efficacy of the test product has been achieved. Based on clinical, pharmacokinetic and statistical data obtained from healthy, adult, male, human subjects under fasting conditions, it was concluded that a single dose of test formulation ‘ZAFIRLUKAST’ containing drug 1000 mg was found to be safe and bioequivalent to the reference formulation ‘ACCOLATE’ containing drug 1000 mg as 90 % confidence interval for the ratios of means of test and reference parameters such as ln-transformed Cmax, AUC0-t and AUC0- of drug is within the bioequivalence acceptance range of 80.00% – 125.00 %.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg.No: 261425015 |
| Uncontrolled Keywords: | Open Label Two Way Two Period ; Randomised ; Single Dose Comparitive Oral Bioavailability Study ; Zafirlukast ; Healthy Volunteers ; Under Fasting Conditions |
| Subjects: | PHARMACY > Pharmacology |
| Depositing User: | Ravindran C |
| Date Deposited: | 19 Mar 2018 10:15 |
| Last Modified: | 21 Mar 2018 07:11 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/6353 |
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