Bioequivalence study of fenofibrate 300 mg capsule (Evothyl® 300 mg) produced by PT Guardian Pharmatama in comparison with the comparator drug (Lipanthyl® 300 mg Capsule manufactured by PT Combiphar, Indonesia registered by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects

1. Background
Registration Number	INA-ZM65S9E
Date of registry approval	13-03-2024
Registration Date	06-03-2024
Secondary identifiers	Yes
Name of issuing authority (for example protocol number, other registries, etc)	BE. 707/EQL/2022
Secondary identifier number
Scientific study title	Bioequivalence study of fenofibrate 300 mg capsule (Evothyl® 300 mg) produced by PT Guardian Pharmatama in comparison with the comparator drug (Lipanthyl® 300 mg Capsule manufactured by PT Combiphar, Indonesia registered by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects
Public (popular study title)	Bioequivalence study of fenofibrate 300 mg capsule (Evothyl® 300 mg) produced by PT Guardian Pharmatama in comparison with the comparator drug (Lipanthyl® 300 mg Capsule manufactured by PT Combiphar, Indonesia registered by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects

2. Sponsor and Funding
Primary Sponsor	PT Guardian Pharmatama
Source(s) of monetary or material support	PT Guardian Pharmatama
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	Ronal Simanjuntak – PT Equilab International
Address for public queries	PT Equilab International, Jl. RS. Fatmawati Persil 33
City	Jakarta
Country	INDONESIA
ZIP	12430
Affiliation for public queries	PT Equilab International
Email address for public queries	info@equilab-int.com
Phone number for public queries	+62 21 7695513, 7515932
Scientific Queries
Name of Contact for scientific queries	Ronal Simanjuntak
Address for scientific queries	PT Equilab International, Jl. RS. Fatmawati Persil 33
City	Jakarta
Country	INDONESIA
ZIP	12430
Affiliation of scientific queries contact	PT Equilab International
Email address for scientific queries	info@equilab-int.com

4. IRB & Regulatory
Ethical Approval number	No. S-30/UN2.F1/ETIK/PPM.00.02/2023
Name of Ethics committee	Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia - RSUPN Dr. Cipto Mangunkusumo
Date of Ethic approval	09-01-2023
Contact details of Ethic Committee (phone, email, and office)	Jl. Salemba 6, Jakarta Pusat; Whatsapp: 0856-8701-608; Telp. 021 315 7008; e-Mail: ec_fkui@yahoo.com
Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB)	RG.01.02.321.02.23.01554/UB

5. Status
Countries of recruitment	Indonesia
Study sites in Indonesia	PT Equilab International
Recruitment status	Complete
Date of first enrollment	02-05-2023
Targeted Sample size	00030 -
Number of enrolled participants	30
Date of study completion (last participant, last visit)	01-06-2023

6. Study Design & Purpose
Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error)	Healthy subjects
Purpose of the study	Bioequivalence study
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)	one of test drug (Evothyl® 300 mg Capsule produced by PT Guardian Pharmatama)
Control intervention (control arm)	one of comparator drug (Lipanthyl® 300 mg Capsule manufactured by PT Combiphar, Indonesia registered by PT Abbott Indonesia, Indonesia)
Intervention assignment	Crossover

7. Eligibility Criteria
Gender inclusion criteria	Male, Female
Minimum age	18
Maximum age	55
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. Preferably non-smokers or smoke less than 10 cigarettes per day. 5. Body mass index within 18 to 25 kg/m2. 6. Vital signs (after 10 minutes rest) were within the following ranges: Systolic blood pressure : 100 – 129 mmHg Diastolic blood pressure : 60 – 84 mmHg Pulse rate : 60 – 90 bpm 7. Willing to practice abstention or use non-hormonal contraception during the study.
Exclusion criteria	1. History of allergy or hypersensitivity or contraindication to fenofibrate or allied drug. 2. Pregnant or lactating female (urinary pregnancy test was applied to female subjects at screening and before taking the study drug). 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness. 4. 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. 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 6. Positive result for COVID-19 rapid antigen test. 7. Clinically significant hematology abnormalities. 8. Clinically significant electrocardiogram (ECG) abnormalities. 9. 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. 10. Past history of anaphylaxis or angioedema. 11. History of drug or alcohol abuse within 12 months prior to screening for this study. 12. Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day. 13. History of any bleeding or coagulative disorders. 14. Presence of difficulty in accessibility of veins in left or right arm. 15. A donation or significant blood loss within 90 days before this study’s first dosing day. 16. 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	AUC0-t dan Cmax
Metric/method of measurement	The plasma concentrations of fenofibric acid were determined by using validated high performance liquid chromatography with ultraviolet detection (HPLC-UV) method.
Timepoint(s) of measurement	Blood samples were drawn before taking the drug, and 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.

9. Study Results
Brief summary of study results	it was concluded that fenofibrate 300 mg capsule (Evothyl® 300 mg) produced by PT Guardian Pharmatama were bioequivalent to the comparator drug (Lipanthyl® 300 mg Capsule manufactured by PT Combiphar, Indonesia registered by PT Abbott Indonesia, Indonesia) when administered under fed condition in healthy subjects.
Date of results summaries	13-07-2023
Participant flow	All of the 30 enrolled subjects were completed the study and included in pharmacokinetic calculation of fenofibric acid
Baseline characteristic
Adverse events	There was no adverse event used during this bioequivalence study
Outcome measures	90% Confidence interval

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	Bioequivalence result