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IJBC 2021, 13(2): 48-53 Back to browse issues page
Efficacy of Deferasirox through Bioequivalence Study in Indonesian Healthy Volunteer
Asti Swari Paramanindita *, Yahdiana Harahap, Tri Rahayu Wijayanti, Windy Lusthom, Budi Prasaja, Evan Widjaja, Monika Sandra, Girinanda Puspanegara
P.T. Clinisindo Laboratories, Jakarta, Indonesia
Abstract:   (568 Views)
Background: Deferasirox is an orally bioavailable synthetic, tridentate iron chelator that binds iron at a 2:1 ratio. The generic brand for this drug is still not available in Indonesia. We aimed to compare the efficacy between the generic drug and its innovator (Exjade®) by a study of bioequivalence in Indonesia among healthy volunteers.
Methods: An open-label, single-dose, two-sequence, randomized two-way crossover study with one-week wash-out period was evaluated in 28 enrolled volunteers. Blood samples were collected up to 60 hours following drug administration. Deferasirox level was determined by HPLC method with ultraviolet detector. The pharmacokinetic parameters tested for bioequivalence assessment were AUC0-t, AUC0-∞, and Cmax.
Results: The 90% confidence intervals obtained by analysis of variance for AUC0-t, AUC0-∞, and Cmax were 83.04%-95.53%, 83.18%-98.88%, and 81.67%-105.47%, respectively. These results were all within the range of 80.00-125.00%.
Conclusion: Our results indicated that a single dose of 500 mg Deferasirox tablet demonstrated similar bioequivalence in terms of rate and extent of absorpstion to single dose of Exjade® 500 mg tablet. 
Keywords: Thalassemia major, Deferasirox, Bioequivalence, Iron chelation, Pharmacokinetics
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: Research | Subject: Adults Hematology & Oncology
Received: 2020/05/6 | Accepted: 2021/04/19 | Published: 2021/07/15
* Corresponding Author Address: Jl. Ulujami Raya No.12, Pesanggrahan, Jakarta Selatan, 12250, Indonesia
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Paramanindita A S, Harahap Y, Wijayanti T R, Lusthom W, Prasaja B, Widjaja E, et al . Efficacy of Deferasirox through Bioequivalence Study in Indonesian Healthy Volunteer. IJBC. 2021; 13 (2) :48-53
URL: http://ijbc.ir/article-1-1001-en.html


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Volume 13, Issue 2 (June 2021 2021) Back to browse issues page
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