Demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed condition
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 th...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2022-01-01
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| Series: | Journal of Advanced Pharmaceutical Technology & Research |
| Subjects: | |
| Online Access: | http://www.japtr.org/article.asp?issn=2231-4040;year=2022;volume=13;issue=2;spage=123;epage=127;aulast=Colaco |
| _version_ | 1818007040603193344 |
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| author | Socorrina Colaco N Ramesh Ramakrishna Shabaraya |
| author_facet | Socorrina Colaco N Ramesh Ramakrishna Shabaraya |
| author_sort | Socorrina Colaco |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-14T05:10:19Z |
| format | Article |
| id | doaj.art-eb3fe1e1cd824d4bad8598b242ff8445 |
| institution | Directory Open Access Journal |
| issn | 2231-4040 0976-2094 |
| language | English |
| last_indexed | 2024-04-14T05:10:19Z |
| publishDate | 2022-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Advanced Pharmaceutical Technology & Research |
| spelling | doaj.art-eb3fe1e1cd824d4bad8598b242ff84452022-12-22T02:10:36ZengWolters Kluwer Medknow PublicationsJournal of Advanced Pharmaceutical Technology & Research2231-40400976-20942022-01-0113212312710.4103/japtr.japtr_362_21Demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed conditionSocorrina ColacoN RameshRamakrishna ShabarayaThe 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.http://www.japtr.org/article.asp?issn=2231-4040;year=2022;volume=13;issue=2;spage=123;epage=127;aulast=Colacofed conditionliquid chromatography–mass spectrometrymetaxaloneoral bioavailabilitypharmacokinetics |
| spellingShingle | Socorrina Colaco N Ramesh Ramakrishna Shabaraya Demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed condition Journal of Advanced Pharmaceutical Technology & Research fed condition liquid chromatography–mass spectrometry metaxalone oral bioavailability pharmacokinetics |
| title | Demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed condition |
| title_full | Demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed condition |
| title_fullStr | Demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed condition |
| title_full_unstemmed | Demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed condition |
| title_short | Demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed condition |
| title_sort | demonstration of relative bioavailability of newly developed and innovator drug metaxalone 800 mg in healthy subjects under fed condition |
| topic | fed condition liquid chromatography–mass spectrometry metaxalone oral bioavailability pharmacokinetics |
| url | http://www.japtr.org/article.asp?issn=2231-4040;year=2022;volume=13;issue=2;spage=123;epage=127;aulast=Colaco |
| work_keys_str_mv | AT socorrinacolaco demonstrationofrelativebioavailabilityofnewlydevelopedandinnovatordrugmetaxalone800mginhealthysubjectsunderfedcondition AT nramesh demonstrationofrelativebioavailabilityofnewlydevelopedandinnovatordrugmetaxalone800mginhealthysubjectsunderfedcondition AT ramakrishnashabaraya demonstrationofrelativebioavailabilityofnewlydevelopedandinnovatordrugmetaxalone800mginhealthysubjectsunderfedcondition |