Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial
Q3
- Autores:
-
Duran, María I.
Ballesteros-Ramírez, Ricardo
Téllez Arévalo, Angélica María
Torregrosa Almonacid, Lilian
Olejua Villa, Peter Alfonso
Galvis Navarrete, Silvia Helena
Urueña, Claudia Patricia
Fiorentino, Susana
- Tipo de recurso:
- Article of investigation
- Fecha de publicación:
- 2022
- Institución:
- Pontificia Universidad Javeriana
- Repositorio:
- Repositorio Universidad Javeriana
- Idioma:
- eng
- OAI Identifier:
- oai:repository.javeriana.edu.co:10554/63820
- Acceso en línea:
- https://www.hindawi.com/journals/ecam/2022/7943001/
http://hdl.handle.net/10554/63820
https://doi.org/10.1155/2022/7943001
- Palabra clave:
- Rights
- License
- Atribución-NoComercial 4.0 Internacional
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| dc.title.spa.fl_str_mv |
Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial |
| title |
Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial |
| spellingShingle |
Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial |
| title_short |
Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial |
| title_full |
Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial |
| title_fullStr |
Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial |
| title_full_unstemmed |
Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial |
| title_sort |
Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trial |
| dc.creator.fl_str_mv |
Duran, María I. Ballesteros-Ramírez, Ricardo Téllez Arévalo, Angélica María Torregrosa Almonacid, Lilian Olejua Villa, Peter Alfonso Galvis Navarrete, Silvia Helena Urueña, Claudia Patricia Fiorentino, Susana |
| dc.contributor.author.none.fl_str_mv |
Duran, María I. Ballesteros-Ramírez, Ricardo Téllez Arévalo, Angélica María Torregrosa Almonacid, Lilian Olejua Villa, Peter Alfonso Galvis Navarrete, Silvia Helena Urueña, Claudia Patricia Fiorentino, Susana |
| dc.contributor.corporatename.spa.fl_str_mv |
Pontificia Universidad Javeriana. Facultad de Medicina. Departamento de Ciencias Fisiológicas |
| dc.contributor.corporatename.none.fl_str_mv |
Pontificia Universidad Javeriana. Facultad de Medicina. Departamento de Cirugía y Especialidades. Cirugía General |
| dc.contributor.javerianateacher.none.fl_str_mv |
Téllez Arévalo, Angélica María Torregrosa Almonacid, Lilian |
| description |
Q3 |
| publishDate |
2022 |
| dc.date.created.none.fl_str_mv |
2022-02-23 |
| dc.date.accessioned.none.fl_str_mv |
2023-03-16T19:56:13Z |
| dc.date.available.none.fl_str_mv |
2023-03-16T19:56:13Z |
| dc.type.local.spa.fl_str_mv |
Artículo de revista |
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http://purl.org/coar/resource_type/c_2df8fbb1 |
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http://purl.org/coar/resource_type/c_2df8fbb1 |
| dc.identifier.spa.fl_str_mv |
https://www.hindawi.com/journals/ecam/2022/7943001/ |
| dc.identifier.issn.spa.fl_str_mv |
1741-427X / 1741-4288 (Electrónico) |
| dc.identifier.uri.none.fl_str_mv |
http://hdl.handle.net/10554/63820 |
| dc.identifier.doi.spa.fl_str_mv |
https://doi.org/10.1155/2022/7943001 |
| dc.identifier.instname.spa.fl_str_mv |
instname:Pontificia Universidad Javeriana |
| dc.identifier.reponame.spa.fl_str_mv |
reponame:Repositorio Institucional - Pontificia Universidad Javeriana |
| dc.identifier.repourl.spa.fl_str_mv |
repourl:https://repository.javeriana.edu.co |
| url |
https://www.hindawi.com/journals/ecam/2022/7943001/ http://hdl.handle.net/10554/63820 https://doi.org/10.1155/2022/7943001 |
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1741-427X / 1741-4288 (Electrónico) instname:Pontificia Universidad Javeriana reponame:Repositorio Institucional - Pontificia Universidad Javeriana repourl:https://repository.javeriana.edu.co |
| dc.language.iso.spa.fl_str_mv |
eng |
| language |
eng |
| dc.relation.citationstartpage.spa.fl_str_mv |
1 |
| dc.relation.citationendpage.spa.fl_str_mv |
11 |
| dc.relation.ispartofjournal.spa.fl_str_mv |
Evidence-Based Complementary and Alternative Medicine |
| dc.relation.citationvolume.spa.fl_str_mv |
2022 |
| dc.rights.licence.*.fl_str_mv |
Atribución-NoComercial 4.0 Internacional |
| dc.rights.coar.spa.fl_str_mv |
http://purl.org/coar/access_right/c_abf2 |
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Atribución-NoComercial 4.0 Internacional http://purl.org/coar/access_right/c_abf2 |
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PDF |
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application/pdf |
| dc.coverage.spatial.spa.fl_str_mv |
Colombia |
| dc.coverage.city.spa.fl_str_mv |
Bogotá (Colombia) |
| institution |
Pontificia Universidad Javeriana |
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http://creativecommons.org/licenses/by-nc/4.0/ |
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Atribución-NoComercial 4.0 Internacionalhttp://purl.org/coar/access_right/c_abf2Duran, María I.Ballesteros-Ramírez, RicardoTéllez Arévalo, Angélica MaríaTorregrosa Almonacid, LilianOlejua Villa, Peter AlfonsoGalvis Navarrete, Silvia HelenaUrueña, Claudia PatriciaFiorentino, SusanaPontificia Universidad Javeriana. Facultad de Medicina. Departamento de Ciencias FisiológicasPontificia Universidad Javeriana. Facultad de Medicina. Departamento de Cirugía y Especialidades. Cirugía GeneralTéllez Arévalo, Angélica MaríaTorregrosa Almonacid, LilianColombiaBogotá (Colombia)2023-03-16T19:56:13Z2023-03-16T19:56:13Z2022-02-23https://www.hindawi.com/journals/ecam/2022/7943001/1741-427X / 1741-4288 (Electrónico)http://hdl.handle.net/10554/63820https://doi.org/10.1155/2022/7943001instname:Pontificia Universidad Javerianareponame:Repositorio Institucional - Pontificia Universidad Javerianarepourl:https://repository.javeriana.edu.coPDFapplication/pdfenghttp://creativecommons.org/licenses/by-nc/4.0/Safety evaluation in healthy Colombian volunteers of P2Et extract obtained from caesalpinia spinosa: Design 3+3 phase I clinical trialArtículo de revistahttp://purl.org/coar/resource_type/c_2df8fbb1Q3Q2The polyphenol-enriched extract called P2Et derived from Caesalpinia spinosa (C. spinosa) had antitumor and immunomodulatory activities reported in breast cancer, leukemia, and melanoma. The aim of this study was to evaluate the safety and maximum tolerated dose of P2Et extract in Colombian healthy volunteers in a phase 1 clinical trial, open labelled, single-arm, dose-escalation design 3 + 3. Seven healthy volunteers were included; P2Et was administrated in capsules of 600 mg/d for 28 days. Analysis by intention to treat was performed. 4 volunteers showed adverse events and discontinued the intervention. 94.6% of AE were grade 1, and most of AE had a reasonable possibility of a relationship with the P2Et (83.8%). We found that the oral administration of P2Et is safe in healthy humans with a maximum tolerated dose of 600 mg/d. There was no severe toxicity; most of the adverse events were mild, without significant changes in the safety parameters evaluated.https://orcid.org/0000-0001-5133-2206https://orcid.org/0000-0002-8468-8716https://orcid.org/0000-0002-5392-7083https://orcid.org/0000-0002-2478-0908https://orcid.org/0000-0001-5529-8279https://orcid.org/0000-0001-5608-3181https://orcid.org/0000-0002-4664-0682Revista Internacional - IndexadaA1No111Evidence-Based Complementary and Alternative Medicine2022ORIGINALSafety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from Caesalpinia spinosa Design 3+3 Phase I Clinical Trial.pdfSafety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from Caesalpinia spinosa Design 3+3 Phase I Clinical Trial.pdfArtículoapplication/pdf1516427http://repository.javeriana.edu.co/bitstream/10554/63820/1/Safety%20Evaluation%20in%20Healthy%20Colombian%20Volunteers%20of%20P2Et%20Extract%20Obtained%20from%20Caesalpinia%20spinosa%20Design%203%2b3%20Phase%20I%20Clinical%20Trial.pdfeaeff79854ee79380b051e12a1e0e152MD51open accessLICENSElicense.txtlicense.txttext/plain; charset=utf-82603http://repository.javeriana.edu.co/bitstream/10554/63820/2/license.txt2070d280cc89439d983d9eee1b17df53MD52open accessTHUMBNAILSafety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from Caesalpinia spinosa Design 3+3 Phase I Clinical Trial.pdf.jpgSafety Evaluation in Healthy Colombian Volunteers of P2Et Extract Obtained from Caesalpinia spinosa Design 3+3 Phase I Clinical Trial.pdf.jpgIM Thumbnailimage/jpeg11443http://repository.javeriana.edu.co/bitstream/10554/63820/3/Safety%20Evaluation%20in%20Healthy%20Colombian%20Volunteers%20of%20P2Et%20Extract%20Obtained%20from%20Caesalpinia%20spinosa%20Design%203%2b3%20Phase%20I%20Clinical%20Trial.pdf.jpgb24a694c5bb9e1040ce157f8f875a8b5MD53open access10554/63820oai:repository.javeriana.edu.co:10554/638202023-03-17 03:01:12.204Repositorio Institucional - Pontificia Universidad Javerianarepositorio@javeriana.edu.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 |