DOSE RATIONALE BIOEQUIVALENCE ASSESSMENT UNDER FASTING CONDITIONS OF ELTROMBOPAG FOR BIOWAIVER MANUFACTURED IN TÜRKİYE

RESEARCH ARTICLE

Nobel Med 2025; 21(1): 22-29

DOSE RATIONALE BIOEQUIVALENCE ASSESSMENT UNDER FASTING CONDITIONS OF ELTROMBOPAG FOR BIOWAIVER MANUFACTURED IN TÜRKİYE

Abdullah Uslu, İlksen Güçarslan, Belkıs Sağıroğlu, Onursal Sağlam, Muradiye Nacak, Aybige Pilancı, Sena Damla Kökçe, Tuğçe Yeşilyurt

ABSTRACT

Objective: This study aimed to evaluate and compare the pharmacokinetics and tolerability of Eltrombopag 25 mg and 75 mg film-coated tablets (test product, Nobel İlaç) in healthy male volunteers with Revolade 25 mg and 75 mg film-coated tablets (reference product, Novartis Pharma GmbH, Germany) through two distinct studies, and the biowaiver of 50 mg dose from bioequivalence study by bracketing approach. Additionally, a bioequivalence waiver for Eltrombopag 50 mg was evaluated using a bracketing approach based on two bioequivalence studies (Study 1 and Study 2) from Eltrombopag (Test Product, Nobel İlaç) 25 mg and 75 mg ffilm-Coated Tablets.

Material and Method: ffasting studies for both doses were conducted using an open-label, randomized, single- dose, two-period, crossover design. A total of 46 and 32 volunteers were enrolled for the Eltrombopag 25 mg and 75 mg dose rationale studies, respectively. Participants were randomly assigned to two sequences (TR/RT) using a computer-generated randomization table.

Results: The geometric mean ratios of the Eltrombopag test and reference products fell within the 90% confidence interval as outlined in the Clinical Study Protocol, confirming bioequivalence. It was concluded that the test products, Eltrombopag 25 mg and 75 mg ffilm Coated Tablets (Nobel İlaç) test products are bioequivalent to originator formulation under fasting conditions.

Conclusion: Two distinct bioequivalence studies (Study 1 and Study 2) conducted for Eltrombopag 25 mg and 75 mg ffilm Coated Tablet doses were positively finalised and found to be bioequivalent to the reference product under fasting conditions. The biowaiver for the 50 mg dose was justified by dose proportional and bracketting approaches in accordance with Turkish Medicines and Medical Devices Agency (TMMDA) and European Medical Agency (EMA) guidelines. These findings support the safe and effective use of Eltrombopag within the therapeutic dose range.

Keywords

Eltrombopag Bracketing approach Bioequivalence Biowaiver Idiopathic thrombocytopenic purpura

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Pubmed Style
Abdullah Uslu, İlksen Güçarslan, Belkıs Sağıroğlu, Onursal Sağlam, Muradiye Nacak, Aybige Pilancı, Sena Damla Kökçe, Tuğçe Yeşilyurt. [DOSE RATIONALE BIOEQUIVALENCE ASSESSMENT UNDER FASTING CONDITIONS OF ELTROMBOPAG FOR BIOWAIVER MANUFACTURED IN TÜRKİYE]. Nobel Med 2025; 21(1): 22-29, English.
Web Style
Abdullah Uslu, İlksen Güçarslan, Belkıs Sağıroğlu, Onursal Sağlam, Muradiye Nacak, Aybige Pilancı, Sena Damla Kökçe, Tuğçe Yeşilyurt. [DOSE RATIONALE BIOEQUIVALENCE ASSESSMENT UNDER FASTING CONDITIONS OF ELTROMBOPAG FOR BIOWAIVER MANUFACTURED IN TÜRKİYE]. www.nobelmedicus.com/en/Article.aspx?m=1716 [Access: Mayıs 24, 2021], English.
AMA (American Medical Association) Style
Abdullah Uslu, İlksen Güçarslan, Belkıs Sağıroğlu, Onursal Sağlam, Muradiye Nacak, Aybige Pilancı, Sena Damla Kökçe, Tuğçe Yeşilyurt. [DOSE RATIONALE BIOEQUIVALENCE ASSESSMENT UNDER FASTING CONDITIONS OF ELTROMBOPAG FOR BIOWAIVER MANUFACTURED IN TÜRKİYE]. Nobel Med 2025; 21(1): 22-29, English.
Vancouver/ICMJE Style
Abdullah Uslu, İlksen Güçarslan, Belkıs Sağıroğlu, Onursal Sağlam, Muradiye Nacak, Aybige Pilancı, Sena Damla Kökçe, Tuğçe Yeşilyurt. [DOSE RATIONALE BIOEQUIVALENCE ASSESSMENT UNDER FASTING CONDITIONS OF ELTROMBOPAG FOR BIOWAIVER MANUFACTURED IN TÜRKİYE]. Nobel Med (2025); 21(1): 22-29, [cited Mayıs 24, 2021], English.
Harvard Style
Abdullah Uslu, İlksen Güçarslan, Belkıs Sağıroğlu, Onursal Sağlam, Muradiye Nacak, Aybige Pilancı, Sena Damla Kökçe, Tuğçe Yeşilyurt. (2025) [DOSE RATIONALE BIOEQUIVALENCE ASSESSMENT UNDER FASTING CONDITIONS OF ELTROMBOPAG FOR BIOWAIVER MANUFACTURED IN TÜRKİYE]. Nobel Med, 21(1): 22-29, English.