Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-FW91Q3G
Tanggal Input Registry : 03-04-2023

27-12-2021
90% Confidence Interval, Cmax and AUCt
N.A
 
Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries.
Bioequivalence Study of Febuxostat 80 mg Film Coated Tablets Manufactured by PT. Bernofarm for PT. Infion in Comparison with Feburic® 80 mg Film Coated Tablets Manufactured by Patheon France SA, imported by PT. Meprofarm Pharmaceutical Industries.
Interventional
Subjects were given a single dose of 80 mg Febuxostat of either formulation (test or reference) with 240 ml of water. Subjects were administered the drug products in a sitting posture. The tablet was swallowed whole without chewing or crushing. Subjects were asked to maintain an upright position (standing or sitting) for 1 hour after dosing.
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Inclusion Criteria:

The inclusion criteria were healthy male or female subjects who/with: 1. had read the subject information and signed informed consent documents 2. age range from 18 – 55 years 3. body mass index between 18 – 25 kg/m2 4. had a normal electrocardiogram 5. had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg) 6. had the heart rate within normal range (60 – 100 bpm) 7. had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. 8.accepted on obligation to use protection (condom) during intercourse with their spouse throughout the study

Exclusion Criteria:

Any of the following criteria excluded the subject from the study: 1. those who were pregnant and/or nursing women. 2. those with history of contraindication or hypersensitivity to Febuxostat or other antihyperuricemic agent or other ingredients in the drugs or a history of serious allergic reaction to any drug, significant allergic disease, allergic reaction, or active allergic. 3. 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. 4. those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities. 5.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. 6. those who had participated in any clinical study within 3 months prior to the study (
 
KET-1112/UN2.F1/ETIK/PPM.00.02/2021
603/STD/PML/2021
Nabila Mudin S