Bioequivalence Study of 200 mg Fenofibrate Capsules Manufactured by PT. Bernofarm in Comparison with 200 mg Lipanthyl® 200 M Capsules Manufactured by Recipharm Fontaine, France, imported and repacked by PT. Combiphar, Bandung, Indonesia.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-XFQ6052
Tanggal Input Registry : 15-12-2022

10-09-2021
90% Confidence Interval, Cmax and AUCt
N.A
 
Bioequivalence Study of 200 mg Fenofibrate Capsules Manufactured by PT. Bernofarm in Comparison with 200 mg Lipanthyl® 200 M Capsules Manufactured by Recipharm Fontaine, France, imported and repacked by PT. Combiphar, Bandung, Indonesia.
Bioequivalence Study of 200 mg Fenofibrate Capsules Manufactured by PT. Bernofarm in Comparison with 200 mg Lipanthyl® 200 M Capsules Manufactured by Recipharm Fontaine, France, imported and repacked by PT. Combiphar, Bandung, Indonesia.
Eksperimental
Subjects were given a single dose of fenofibrate 200 mg of either formulation (test or reference) with 240 ml of water.
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Inclusion Criteria:

The inclusion criteria were healthy subjects who/with: - had read the subject information and signed informed consent documents - healthy male and female - 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 was any intercourse with their spouse during study

Exclusion Criteria:

This study was not eligible for: - those who were pregnant and/or nursing condition. - those with a history of hypersensitivity to fenofibrate, or other anti-cholesterol, 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 gallbladder disease. - those with chronic or acute pancreatitis. - those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities. - 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 (< 90 days). - those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study. - those who were smoked more than 10 cigarettes a day. - those with a history of travelling to another city within the last 14 days - those with a history of direct contact with a COVID-19 positive person in the subject’s neighborhood - those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days - those who were positive to SARS CoV-2 antigen test - those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential). - those with a history of drug or alcohol abuse within 12 months prior to screening for this study. - those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-519/UN2.F1/ETIK/PPM.00.02/2021
N.A
RG.01.02.321.07.21.00251/UB
586/STD/PML/2021
Nabila Mudin S