Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries.
Tahapan Penelitian : Complete
PT Darya-Varia Laboratoria Tbk.
PT Equilab International
Tanggal Input Registry : 30-03-2023
|Tanggal Antisipasi Studi||25-10-2022|
|Outcome Primer||The 90% CI of the test/comparator geometric mean ratios for AUC0-t and Cmax|
|Judul Penelitian Popular||Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries.|
|Judul Penelitian Ilmiah||Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries.|
|Intervensi||The participating subjects were given orally one film-coated caplet of test drug (febuxostat 80 mg film-coated caplet produced by PT Darya-Varia Laboratoria Tbk.) or one film-coated tablet of comparator drug (Feburic® 80 mg Film-Coated Tablet manufactured by Patheon France, S.A., France, imported by PT Meprofarm Pharmaceutical Industries, Indonesia)|
|Jumlah Subyek Penelitian||36|
Inclusion Criteria:(1) Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study; (2) Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation; (3) Aged 18 – 55 years inclusive; (4) Body mass index within 18 to 25 kg/m2; (5) Vital signs (after 10 minutes rest) were within the ranges (Systolic blood pressure : 100 – 129 mmHg; Diastolic blood pressure : 60 – 84 mmHg; Pulse rate : 60 – 90 bpm); (6) Willing to practice abstention or non-hormonal contraception during the study.
Exclusion Criteria:(1) History of allergy or hypersensitivity or contraindication to febuxostat or allied drugs; (2) Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug); (3) Smokers; (4) Any major illness in the past 90 days or clinically significant ongoing chronic medical illness; (5) Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc; (6) Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV; (7) Positive result for COVID-19 rapid antigen test; (8) Clinically significant hematology abnormalities; (9) Clinically significant electrocardiogram (ECG) abnormalities; (10) Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery; (11) Past history of anaphylaxis or angioedema; (12) History of drug or alcohol abuse within 12 months prior to screening for this study; (13) Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day; (14) History of any bleeding or coagulative disorders; (15) Presence of difficulty in accessibility of veins in left or right arm; (16) A donation or significant blood loss within 90 days before this study’s first dosing day; (17) Intake of any prescription, non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
|Nomor Persetujuan Etik||No. S-532/UN2.F1/ETIK/PPM.00.02/2022|
|Nomor Persetujuan Material Transfer Agreement|
|Nomor Persetujuan Pelaksanaan Uji Klinik|
|Other Study ID Numbers||BE. 710/EQL/2022|
|Contact Person||Ronal Simanjuntak|