Bioequivalence study of fenofibrate 160 mg film-coated caplet produced by PT Gracia Pharmindo in comparison with the comparator drug (Lipanthyl® Supra 160 Film-Coated Tablet manufactured by Recipharm Fontaine, France imported by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects
Tahapan Penelitian : Initial
Sponsor:
PT. Gracia Pharmindo
Mitra Pelaksana:
PT. Equilab International
No Registry
INA-CDGHAWP
Tanggal Input Registry : 19-11-2024
Tracking Information | |
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Tanggal Antisipasi Studi | 31-07-2024 |
Outcome Primer | Bioequivalence is concluded if the 90% Confidence Interval (CI) of the Test/Reference geometric means ratio is in the range of 80.00-125.00% with 80% power and 0.05 alpha, for AUC0-72h and Cmax. |
Outcome Skunder | |
Descriptive Information | |
Judul Penelitian Popular | Bioequivalence study of fenofibrate 160 mg film-coated caplet produced by PT Gracia Pharmindo in comparison with the comparator drug (Lipanthyl® Supra 160 Film-Coated Tablet manufactured by Recipharm Fontaine, France imported by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects |
Judul Penelitian Ilmiah | Bioequivalence study of fenofibrate 160 mg film-coated caplet produced by PT Gracia Pharmindo in comparison with the comparator drug (Lipanthyl® Supra 160 Film-Coated Tablet manufactured by Recipharm Fontaine, France imported by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects |
Jenis Penelitian | Interventional |
Intervensi | Not Specified |
Jumlah Subyek Penelitian | 24 |
Recruitment Information | |
Eligibility Criteria | Inclusion Criteria: Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study; 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 the screening and could be considered healthy based on the evaluation; Aged 18-55 years inclusive; Preferably non-smokers or smoke less than 10 cigarettes per day; Body mass index within 18 to 25 kg/m2; Vital signs (after 10 minutes rest) must be within the following ranges: Systolic blood pressure: 100 – 129 mmHg, Diastolic blood pressure: 60 – 84 mmHg, Pulse rate: 60 – 90 bpm; Willing to practice abstention or use non-hormonal contraception during the study.Exclusion Criteria: History of allergy or hypersensitivity or contraindication to fenofibrate or allied drugs; Pregnant or lactating female (urinary pregnancy test will be applied to female subjects at screening and before taking the study drug); Any major illness in the past 90 days or clinically significant ongoing chronic medical illness; 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; Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV; Only complete primary COVID-19 vaccination and tested positive in COVID-19 rapid antigen test at screening and during check-in (applied during transition phase from pandemic situation); Clinically significant hematology abnormalities; Clinically significant electrocardiogram (ECG) abnormalities; 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; Past history of anaphylaxis or angioedema; History of drug or alcohol abuse within 12 months prior to screening for this study; Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day; History of any bleeding or coagulative disorders; Presence of difficulty in accessibility of veins in left or right arm; A donation or significant blood loss within 90 days before this study’s first dosing day; 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. |
Administrative Information | |
Nomor Persetujuan Etik | KET-418/UN2.F1/ETIK/PPM.00.02/2024 dated 18 March 2024 and S-346/UN2.F1/ETIK/PPM.00.02/2024 dated 03 June 2024 |
Nomor Persetujuan Material Transfer Agreement | Not applicable |
Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
Other Study ID Numbers | |
Contact Person | PT. Gracia Pharmindo |