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

1. Background
Registration Number	INA-CDGHAWP
Date of registry approval	19-11-2024
Registration Date	19-11-2024
Secondary identifiers	No
Name of issuing authority (for example protocol number, other registries, etc)
Secondary identifier number
Scientific study title	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
Public (popular study title)	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

2. Sponsor and Funding
Primary Sponsor	PT. Gracia Pharmindo
Source(s) of monetary or material support	Company
Other partners	PT. Equilab International

3. Contact details
Principal Investigator
Principal investigator	dr. Danang Agung Yunaidi
City	Jakarta
Country	Indonesia
Principal investigator's affiliation	PT. Equilab International
Principal Investigator's email address	danang@equilab-int.com
Public Queries
Contact person name for public queries	PT. Gracia Pharmindo
Address for public queries	Kawasan Industri Dwipapuri Blok M-30, Jl. Raya Rancaekek km 24.5
City	Sumedang
Country	Indonesia
ZIP	45364
Affiliation for public queries	PT. Gracia Pharmindo
Email address for public queries	registrasi@gracia.co.id
Phone number for public queries	+62 22 7780033
Scientific Queries
Name of Contact for scientific queries	dr. Natalia Denda Wijaya
Address for scientific queries	Jl. RS. Fatmawati Persil 33, Jakarta 12430 - Indonesia
City	Jakarta
Country	Indonesia
ZIP	12430
Affiliation of scientific queries contact	PT. Equilab International
Email address for scientific queries	Jl. RS. Fatmawati Persil 33, Jakarta 12430 - Indonesia

4. IRB & Regulatory
Ethical Approval number	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
Name of Ethics committee	Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
Date of Ethic approval	18-03-2024
Contact details of Ethic Committee (phone, email, and office)	Phone: +62 21 3912477 Email: humas@fk.ui.ac.id; office@fk.ui.ac.id Office: Faculty of Medicine Building, University of Indonesia, Jl. Salemba Raya No. 6, Jakarta
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	RG.01.02.321.07.24.02754/UB

5. Status
Countries of recruitment	Indonesia
Study sites in Indonesia	PT. Equilab International
Recruitment status	Initial
Date of first enrollment	31-07-2024
Targeted Sample size	00024 -
Number of enrolled participants	24
Date of study completion (last participant, last visit)

6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	Particular health conditions or problems being prevented
Purpose of the study	To find out whether the bioavailability of fenofibrate 160 mg film-coated caplet, NOFIRAT 160 produced by PT Gracia Pharmindo is equivalent to that of the comparator drug (Lipanthyl® Supra 160 Film-Coated Tablet manufactured by Recipharm Fontaine, France
Study type	Interventional
Interventional Study category	Bioequivalence study
Method of allocation
Description of the allocation concealment mechanism and sequence generation
Masking
Study intervention (study arm)	Not Specified
Control intervention (control arm)	Not Specified
Intervention assignment	Crossover

7. Eligibility Criteria
Gender inclusion criteria	Male, Female
Minimum age	18
Maximum age	55
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.

8. Study Outcome
Primary Outcome
Name of primary outcome	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.
Metric/method of measurement	The fenofibric acid plasma concentrations will be measured using a validated high performance liquid chromatography with ultraviolet detection (HPLC-UV) method and according to the bioanalytical laboratory’s standard operating procedures and applicable regulatory requirements.
Timepoint(s) of measurement	A 5 mL blood sample will be drawn by vein puncture within 1 hour before drug administration. Subsequent blood samples will be drawn 5 mL each at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 24.00, 36.00, 48.00, and 72.00 hours after drug administration (±2 minutes for post dose in-house blood draws and ±90 minutes for post dose ambulatory blood draws). The total volume of blood drawn will be about 180 mL (including 10 mL for screening and 85 mL during study at each period).

9. Study Results
Brief summary of study results
Date of results summaries
Participant flow
Baseline characteristic
Adverse events
Outcome measures

10. Publication
URL hyperlink(s) related to results and publications
IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD))	No
Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses)
Other important informations	Not Specified