Cargando…

Open-Label, Phase I, Pharmacokinetic Studies in Healthy Chinese Subjects to Evaluate the Bioequivalence and Food Effect of a Novel Formulation of Abiraterone Acetate Tablets

PURPOSE: Abiraterone acetate tablets (I)(N-AbA) is a novel tablet co-formulated with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). This study aimed to compare the pharmacokinetics, bioequivalence, safety, and food effects of N-AbA with the reference ZYTIGA(®) (R-AbA...

Descripción completa

Detalles Bibliográficos
Autores principales:	Feng, Zeying, Liu, Yaxin, Kuang, Yun, Yang, Shuang, Li, Jinlei, Ye, Ling, Huang, Jie, Pei, Qi, Huang, Yuanyuan, Yang, Guoping
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Dove 2022
Materias:	Original Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8740623/ https://www.ncbi.nlm.nih.gov/pubmed/35018094 http://dx.doi.org/10.2147/DDDT.S339305

Ejemplares similares

Pharmacokinetics and Bioequivalence of Abiraterone Acetate Tablets in Healthy Chinese Volunteers: An Open, Randomized, Single-Dose, Three-Period, Three-Sequence Crossover Study
por: Wu, Zhao-xin, et al.
Publicado: (2023)

Impact of an alternative steroid on the relative bioavailability and bioequivalence of a novel versus the originator formulation of abiraterone acetate
por: Hussaini, Azra, et al.
Publicado: (2017)

Development of Abiraterone Acetate Nanocrystal Tablets to Enhance Oral Bioavailability: Formulation Optimization, Characterization, In Vitro Dissolution and Pharmacokinetic Evaluation
por: Liu, Yuanfen, et al.
Publicado: (2022)

Comparative Bioequivalence of Tablet and Capsule Formulations of Ulotaront and the Effect of Food on the Pharmacokinetics of the Tablet Form in Humans
por: Chen, Yu-Luan, et al.
Publicado: (2023)

Pharmacokinetics and Bioequivalence Evaluation of Cyclobenzaprine Tablets
por: Brioschi, Tatiane Maria de Lima Souza, et al.
Publicado: (2013)

Pharmacokinetics and bioequivalence assessment of optimized directly compressible Aceclofenac (100 mg) tablet formulation in healthy human subjects
por: Bushra, Rabia, et al.
Publicado: (2020)

Open-label, phase I, pharmacokinetic studies of abiraterone acetate in healthy men
por: Acharya, M., et al.
Publicado: (2012)

Bioequivalence study of two formulations of bisoprolol fumarate film-coated tablets in healthy subjects
por: Tjandrawinata, Raymond R, et al.
Publicado: (2012)

Comparison of a Novel Formulation of Abiraterone Acetate vs. the Originator Formulation in Healthy Male Subjects: Two Randomized, Open-Label, Crossover Studies
por: Goldwater, Ronald, et al.
Publicado: (2017)

Pharmacokinetics and Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Crossover Study
por: Shi, Ping, et al.
Publicado: (2021)

Pharmacokinetics and bioequivalence of Ezetimibe tablet versus Ezetrol®:an open-label, randomized, two-sequence crossover study in healthy Chinese subjects
por: Sun, Feifei, et al.
Publicado: (2023)

Bioequivalence study of two formulations of candesartan cilexetil tablet in healthy subjects under fasting conditions
por: Tjandrawinata, Raymond R, et al.
Publicado: (2013)

Bioequivalence of the 4-mg Oral Granules and Chewable Tablet Formulations of Montelukast
por: Knorr, Barbara, et al.
Publicado: (2010)

Evaluation of Pharmacokinetics and Safety with Bioequivalence of Ibuprofen Sustained-Release Capsules of Two Formulations, in Chinese Healthy Volunteers: Bioequivalence Study
por: Huang, Chunqi, et al.
Publicado: (2023)

Abiraterone Acetate
Publicado: (2012)

Bioequivalence of two tablet formulations of cefpodoxime proxetil in beagle dogs
por: Gao, Yan-Yan, et al.
Publicado: (2022)

Bioequivalence Evaluation of Two Formulations of Tenofovir Alafenamide Tablets in Healthy Subjects Under Fasting and Fed Conditions
por: Li, Qiuying, et al.
Publicado: (2021)

Evaluation of Bioequivalency and Pharmacokinetic Parameters for Two Formulations of Glimepiride 1-mg in Chinese Subjects
por: Ju, Gehang, et al.
Publicado: (2020)

Pharmacokinetics and bioequivalence of two cyclosporine oral solution formulations in cats
por: Yang, Yuxin, et al.
Publicado: (2022)

Pharmacokinetics and bioequivalence of sunitinib and Sutent(®) in Chinese healthy subjects: an open-label, randomized, crossover study
por: Wang, Yanli, et al.
Publicado: (2023)

Bioequivalence of perampanel fine granules and tablets in healthy Japanese subjects
por: Shiba, Sari, et al.
Publicado: (2020)

Physiologically Based Pharmacokinetic Model Development and Verification for Bioequivalence Testing of Bempedoic Acid Oral Suspension and Reference Tablet Formulation
por: Amore, Benny M., et al.
Publicado: (2023)

Bioequivalence of saxagliptin/dapagliflozin fixed‐dose combination tablets compared with coadministration of the individual tablets to healthy subjects
por: Vakkalagadda, Blisse, et al.
Publicado: (2016)

Pharmacokinetics, Bioequivalence and Safety Evaluation of Two Ticagrelor Tablets Under Fasting and Fed Conditions in Healthy Chinese Subjects
por: Wang, Jin, et al.
Publicado: (2021)

Formulation and Bioequivalence of Two Valsartan Tablets After a Single Oral Administration
por: Zaid, Abdel Naser, et al.
Publicado: (2011)

Bioequivalence of 2 Naproxen Sodium Tablet Formulations in Healthy Male and Female Volunteers
por: Sugár, Dalma, et al.
Publicado: (2019)

Comparative Pharmacokinetics and Bioequivalence Evaluation of Two Formulations of Pramipexole Dihydrochloride Extended-Release Tablets in Healthy Chinese Subjects Under Fasted and Fed States: A Randomized, Open-Label, Single-Dose, Two-Period Crossover Clinical Trial
por: Yang, Ling, et al.
Publicado: (2023)

Pharmacokinetics and bioequivalence study of esomeprazole magnesium enteric-coated tablets 20 mg in healthy Chinese subjects under fasting and fed conditions
por: Ding, Ying, et al.
Publicado: (2023)

The Bioequivalence and Effect of Food on the Pharmacokinetics of a Fixed‐Dose Combination Tablet Containing Rosuvastatin and Ezetimibe in Healthy Japanese Subjects
por: Nishida, Chisato, et al.
Publicado: (2019)

Development of Clinically Optimized Sitagliptin and Dapagliflozin Complex Tablets: Pre-Formulation, Formulation, and Human Bioequivalence Studies
por: Kang, So-Jin, et al.
Publicado: (2023)

Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem®) for bioequivalence in a randomized, open-label, two-period study
por: Lefèvre, Gilbert, et al.
Publicado: (2013)

Pharmacokinetics and Bioequivalence of Two Formulations of Febuxostat 40-Mg and 80-Mg Tablets: A Randomized, Open-Label, 4-Way Crossover Study in Healthy Chinese Male Volunteers
por: Luo, Zhu, et al.
Publicado: (2016)

Pharmacokinetics and Bioequivalence Study of Hydroxychloroquine Sulfate Tablets in Chinese Healthy Volunteers by LC–MS/MS
por: Fan, Hong-wei, et al.
Publicado: (2015)

Pharmacokinetics and Bioequivalence of Memantine Tablet and a New Dry Syrup Formulation in Healthy Japanese Males: Two Single-Dose Crossover Studies
por: Maekawa, Yutaro, et al.
Publicado: (2019)

Bioequivalence of two oral formulations of tebipenem pivoxil hydrobromide in healthy subjects
por: Gupta, Vipul K., et al.
Publicado: (2022)

Bioequivalence and Pharmacokinetic Profiles of Generic and Branded Obeticholic Acid in Healthy Chinese Subjects Under Fasting and Fed Conditions
por: Wang, Meng-Na, et al.
Publicado: (2021)

Corrigendum: Pharmacokinetics and bioequivalence study of esomeprazole magnesium enteric-coated tablets 20 mg in healthy Chinese subjects under fasting and fed conditions
por: Ding, Ying, et al.
Publicado: (2023)

Pharmacokinetic Bioequivalence of Two Inhaled Tiotropium Bromide Formulations in Healthy Volunteers
por: Algorta, Jaime, et al.
Publicado: (2016)

Pharmacokinetics and bioequivalence of two imidocarb formulations in cattle after subcutaneous injection
por: Wang, Honglei, et al.
Publicado: (2022)

Dose Finding and Food Effect Studies of a Novel Abiraterone Acetate Formulation for Oral Suspension in Comparison to a Reference Formulation in Healthy Male Subjects
por: Jordán, Tamás, et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_s5fm6iesoqnu4hld8fi22aalrm