Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Catur Dakwah Crane Farmasi for PT. Pharma Laboratories in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-0E8MRMC
Tanggal Input Registry : 04-04-2023

27-09-2021
Primary Cmax (ng.mL-1) AUCt (h.ng.mL-1)
Secondary AUCinf (h.ng.mL-1) Tmax (h) T½ (h)
 
Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Catur Dakwah Crane Farmasi for PT. Pharma Laboratories in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia, Indonesia
Bioequivalence Study of 300 mg Fenofibrate Capsules Manufactured by PT. Catur Dakwah Crane Farmasi for PT. Pharma Laboratories in Comparison with 300 mg Lipanthyl® Capsules Manufactured by PT. Combiphar, Bandung, Indonesia for PT. Abbott Indonesia, Indonesia
Interventional
NA
22
 

Inclusion Criteria:

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. - agreed to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse throughout the study

Exclusion Criteria:

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 smoke 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 were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-564/UN2.F1/ETIK/PPM.00.02/2021
619/STD/PML/2021
Utik Paraswati