Bioequivalence Study of Deferasirox 500 mg Dispersible Tablets Manufactured by PT. Bernofarm in Comparison with Exjade® 500 mg Dispersible Tablets Manufactured by Novartis Pharma Stein AG for Novartis Pharma AG, Basel, Switzerland, Imported by PT. Novartis Indonesia, Jakarta, Indonesia

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-WQ16ZYB
Tanggal Input Registry : 25-11-2022

25-05-2021
90% Confidence Interval, Cmax and AUCt
N.A
 
Bioequivalence Study of Deferasirox 500 mg Dispersible Tablets Manufactured by PT. Bernofarm in Comparison with Exjade® 500 mg Dispersible Tablets Manufactured by Novartis Pharma Stein AG for Novartis Pharma AG, Basel, Switzerland, Imported by PT. Novartis Indonesia, Jakarta, Indonesia
Bioequivalence Study of Deferasirox 500 mg Dispersible Tablets Manufactured by PT. Bernofarm in Comparison with Exjade® 500 mg Dispersible Tablets Manufactured by Novartis Pharma Stein AG for Novartis Pharma AG, Basel, Switzerland, Imported by PT. Novartis Indonesia, Jakarta, Indonesia
Eksperimental
subjects were given a single dose of 500 mg deferasirox of either formulation (test or reference) with 240 ml of water. Tablets should not be chewed or swallowed whole. The drug was completely dispersed by stirring in a glass of water (100 to 200 ml) until a fine suspension was obtained. Subjects administered the suspension in sitting posture. After swallowing the suspension, any residue were re-suspended in the remaining water, and swallowed all. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing.
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Inclusion Criteria:

The inclusion criteria were healthy male or female subjects who/with: -had read the subject information and signed informed consent documents -age range from 18 – 55 years -body mass index between 18 – 25 kg/m2 -had a normal electrocardiogram -had the blood pressure within normal range (systolic 90 - 120 mmHg and diastolic 60 - 80 mmHg) -had the heart rate within normal range (60 – 100 bpm) -had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. -acceptance to use protection (condom) if there is any intercourse with their spouse during study

Exclusion Criteria:

This study was not eligible for: -those who were pregnant and/or nursing condition (for women). -those with history of contraindication or hypersensitivity to deferasirox, or other iron chelating agent, or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction. -those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g., chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease. -those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities. -those with pre-existing iron deficiency (for female subjects) -those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day. -those who had participated in any clinical study within 3 months prior to the study (
 
KET-194/UN2.F1/ETIK/PPM.00.02/2021
N.A
RG.01.02.321.04.21.00090/UB
573/STD/PML/2020
Nabila Mudin Sutanto