Demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed condition

Autor: Socorrina Colaco, N Ramesh, Ramakrishna Shabaraya
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Journal of Advanced Pharmaceutical Technology & Research, Vol 13, Iss 2, Pp 123-127 (2022)
Druh dokumentu: article
ISSN: 2231-4040
0976-2094
DOI: 10.4103/japtr.japtr_362_21
Popis: The notable unbiased of this research work was to evaluate the well-being and effectiveness of metaxalone by administering the newly developed test and reference drug. A two-period, two-categorization, crossover bioavailability study in fed conditions. Eleven participants were dosed and completed the trial successfully. The drugs were administered by way of a schedule. Samples collected in both periods for pharmacokinetic evaluation. Plasma samples analyzed using a validated method. Pharmacokinetic parameters for investigational and reference products were calculated using the metaxalone drug concentration and safety of the participants monitored by measurement of vital sign. Relative estimation factors calculated for Cmax, Tmax, area under the curve (AUC) t, AUC inf, K el, half-life, and 90% confidence intervals applied for to check for whether reference and test products are equivalent. The experimental part of the study was completed with no major adversarial event. No losses or stern adverse events transpired throughout the course of the experiment. The assessment product is analogous to reference product in relation to degree and extent of absorption. The outcome of this study indicates the newly developed drug is equivalent to the innovator drug and medication was well tolerated by all participants.
Databáze: Directory of Open Access Journals
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