TY - JOUR
T1 - Efficacy of deferasirox through bioequivalence study in indonesian healthy volunteer
AU - Paramanindita, Asti Swari
AU - Harahap, Yahdiana
AU - Wijayanti, Tri Rahayu
AU - Lusthom, Windy
AU - Prasaja, Budi
AU - Widjaja, Evan
AU - Sandra, Monika
AU - Puspanegara, Girinanda
N1 - Funding Information:
This study was supported by P.T. Novell Pharmaceutical Laboratories, Jakarta, Indonesia Conflict of Interest: Asti Swari Paramanindita, Tri Rahayu Wijayanti, Windy Lusthom, Budi Prasaja, Evan Widjaja, Monika Sandra are employees of the contract organization P.T. Clinisindo Laboratories, Jakarta, Indonesia.
Publisher Copyright:
© 2021, Iranian Pediatric Hematology and Oncology Society. All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - Bioequivalence
KW - Deferasirox
KW - Iron chelation
KW - Pharmacokinetics
KW - Thalassemia major
UR - http://www.scopus.com/inward/record.url?scp=85111407156&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:85111407156
SN - 2008-4595
VL - 13
SP - 48
EP - 53
JO - Iranian Journal of Blood and Cancer
JF - Iranian Journal of Blood and Cancer
IS - 2
ER -