Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Kalbe Farma, Tbk for PT. Hexpharm Jaya in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-NDZ13R0
Tanggal Input Registry : 12-09-2023

05-05-2023
Cmax, AUC0-t
 
Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Kalbe Farma, Tbk for PT. Hexpharm Jaya in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia.
Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Kalbe Farma, Tbk for PT. Hexpharm Jaya in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia.
Interventional
300 mg Fenofibrate Capsules
24
 

Inclusion Criteria:

Subjects had read the subject information and signed informed consent documents, Subjects healthy male and female, Subjects age range from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had the blood pressure within normal range (systolic 90 – 120 mmHg and diastolic 60-80 mmHg), Subjects had the heart rate within normal range (60 – 100 bpm), Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, Subjects accepted to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout the study

Exclusion Criteria:

Those who were pregnant and/or nursing condition, Those with a history of contraindication or 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 pharmacokinetics 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 history or presence of any coagulation disorder or clinically significant hematology abnormalities, Those who using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetics 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 smoked more than 10 cigarettes a day, Those who had history of travelling to another city within the last 14 days without following health authority regulation, Those who had of direct contact with a COVID-19 positive person in the subject’s neighborhood within 5 days prior to screening, Those who had history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days, Those who was positive to SARS-CoV-2 antigen test, Those who was positive to HIV, HBsAg, and HCV tests (to be kept confidential), Those who had history of drug or alcohol abuse within 12 months prior to screening for this study, Those who was unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-1211/UN2.F1/ETIK/PPM.00.02/2022
Not applicable
PPUK/PPUB number
683/STD/PML/2022
Nabila Mudin S