Saravanan, V (2014) An Open-Label, Balanced, Randomized, Two-Treatment, Two-Period, Two Sequence, Single Dose, Two-Way Crossover, Bioequivalence Study of Lamotrigine 50 Mg Tablets in Healthy, Adult, Human Subjects Under Fed Conditions. Masters thesis, Mohamed Sathak A.J. College of Pharmacy, Chennai.
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Abstract
Pharmacology, bioavailability (BA) is a subcategory of absorption and is the fraction of an administered dose of unchanged drug that reaches the systemic circulation, which is one of the principal pharmacokinetic properties of drug. By definition, when a medication is administered intravenously, its bioavailability is 100%. However, when a medication is administered via other routes (such as oral), its bioavailability generally decreases (due to incomplete absorption and first-pass metabolism) or may vary from patient to patient. Bioavailability is one of the essential tools in pharmacokinetics as bioavailability The main objective of bioequivalence studies is to assure the efficacy and safety of generic formulations. Therefore, two formulations of the same drug are considered to be bioequivalent and ergo therapeutically equivalent if they exhibit a comparable extent and rate of absorption, when they are administered in the same molar dose and under similar experimental conditions. The study procedure was followed as per the GCP, ICMR, and Ethics committee guidelines to ensure the wellbeing of the study subjects. The duration of the study was followed as 22 days with the wash out period of 14 days to compare the reference and test products of Lamotrigine 20 mg tablets. The 90% confidence interval of the least square mean of Cmax, AUC0-t and AUC0-∞ were (99.78 % to 106.17 %), (101.11 % to 108.29 %) and (102.05 % to 110.03 %), respectively, within the limit of 80.00 % and 125.00 %. Two adverse events were reported during in-house confinement for the test product. There were no adverse events reported during post study evaluation and no serious adverse events) reported during the study. It can be reasonably concluded that both the test and reference products were comparable for safety at the selected dose level.
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | Randomized ; Treatment ; Bioequivalence Study ; Lamotrigine 50 Mg Tablets. |
| Subjects: | PHARMACY > Pharmacology |
| Depositing User: | Ravindran C |
| Date Deposited: | 20 Jul 2017 09:09 |
| Last Modified: | 01 Feb 2018 17:12 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/1998 |
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