Bioequivalence Assessment of an Oral Fixed-Dose Formulation of Dutasteride-Tamsulosin 0.5 mg/0.4 mg: A Randomized, Single-Blind, Single-Dose, 2-Period Crossover Study in Mexican Population Under Fasted Conditions.
bioavailability
bioequivalence
dutasteride
generics
tamsulosin
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
received:
26
05
2021
accepted:
26
07
2021
pubmed:
13
8
2021
medline:
5
4
2022
entrez:
12
8
2021
Statut:
ppublish
Résumé
The aim of the present study was to compare the bioavailability and to demonstrate the bioequivalence between a dutasteride-tamsulosin 0.5 mg/0.4 mg capsule formulation and the regulatory reference drug (Combodart®, GlaxoSmithKline). A randomized, single-blind, single-dose, 2-way crossover study under fasting conditions, with at least a 28-day washout period was carried out in healthy volunteers. Plasma concentrations of drugs were determined by high-performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic analysis included maximum plasma concentration (C
Substances chimiques
Tablets
0
Tamsulosin
G3P28OML5I
Dutasteride
O0J6XJN02I
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
318-323Informations de copyright
© 2021, The American College of Clinical Pharmacology.
Références
Lim KB. Epidemiology of clinical benign prostatic hyperplasia. Asian J Urol. 2017;4(3):148-151.
Lokeshwar SD, Harper BT, Webb E, et al. Epidemiology and treatment modalities for the management of benign prostatic hyperplasia. Transl Androl Urol. 2019;8(5):529-539.
Egan KB. The epidemiology of benign prostatic hyperplasia associated with lower urinary tract symptoms: prevalence and incident rates. Urol Clin North Am. 2016;43(3):289-297.
Dimitropoulos K, Gravas S. Fixed-dose combination therapy with dutasteride and tamsulosin in the management of benign prostatic hyperplasia. Ther Adv Urol. 2016;8(1):19-28.
Roehrborn CG, Rosen RC. Medical therapy options for aging men with benign prostatic hyperplasia: focus on alfuzosin 10 mg once daily. Clin Interv Aging. 2008;3(3):511-524.
Kurczewski R, Bowen C, Collins D, Zhu J, Serbest G, Manyak M. Bioequivalence studies of a reformulated dutasteride and tamsulosin hydrochloride combination capsule and a commercially available formulation. Clin Pharmacol Drug Dev. 2017;6(5):508-516.
Keating GM. Fosfomycin trometamol: a review of its use as a single-dose oral treatment for patients with acute lower urinary tract infections and pregnant women with asymptomatic bacteriuria. Drugs. 2013;73(17):1951-1966.
Zhou Z, Cui Y, Wu J, Ding R, Cai T, Gao Z. Meta-analysis of the efficacy and safety of combination of tamsulosin plus dutasteride compared with tamsulosin monotherapy in treating benign prostatic hyperplasia. BMC Urol. 2019;19(1):1-12.
Stevens H, Huys I. Innovative approaches to increase access to medicines in developing countries. Front Med. 2017;4:1-6.
Ito Y, Hara K, Kobayashi Y. The effect of inertia on brand-name versus generic drug choices. J Econ Behav Organ. 2020;172:364-379.
World Medical Association. World Medical Association Declaration of Helsinki. JAMA. 2013;310(20):2191.
Shakya K, Hakooz NM, Arafat TA, et al. Quantification of tamsulosin in human plasma by high-perfomance liquid chromatography coupled with electrospray tandem mass spectrometry. Acta Chromatogr. 2010;22(1):99-116.
Prasaja B, Harahap Y, Lusthom W, et al. A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers. Eur J Drug Metab Pharm. 2011;36(2):109-113.
Schuirmann, D.J. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharm Biopharm. 1987;15:657-680.
Chow SC. Bioavailability and bioequivalence in drug development. Interdiscip Rev Comput Stat. 2014;6(4):304-312.
Shein-Chung JL. Design and Analysis of Bioavailability and Bioequivalence Studies. 3rd ed. New York: Chapman Hall/CRC Press, Taylor & Francis; 2008.
Fossler MJ, Collins DA, Thompson MM, Nino A, Bianco JJ, Chetty D. Pharmacokinetic bioequivalence studies of a fixed-dose combination of tamsulosin and dutasteride in healthy volunteers. Clin Drug Investig. 2014;34(5):335-349.
Gaudreault J, Potvin D, Lavigne J, Lalonde RL. Truncated area under the curve as a measure of relative extent of bioavailability: evaluation using experimental data and Monte Carlo simulations. Pharm Res. 1998;15(10):1621-1629.
Sathe P, Venitz J, Lesko L. Evaluation of truncated areas in the assessment of bioequivalence of immediate release formulations of drugs with long half-lives and of Cmax with different dissolution rates. Pharm Res. 1999;16(6):939-943.