Bioequivalence Study of Fluconazole 150 mg Capsules Manufactured by PT Interbat in Comparison with Diflucan® 150 mg Capsules Manufactured by PT Pfizer Indonesia, Jakarta, Indonesia, Under the Authority of Pfizer Inc., New York, N.Y., USA in Healthy Subjects under Fasting Condition

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Pharma Metric Labs
No Registry
INA-3AFOCSNG
Tanggal Input Registry : 26-03-2025

04-02-2025
Cmax and AUCt
 
Bioequivalence Study of Fluconazole 150 mg Capsules Manufactured by PT Interbat in Comparison with Diflucan® 150 mg Capsules Manufactured by PT Pfizer Indonesia, Jakarta, Indonesia, Under the Authority of Pfizer Inc., New York, N.Y., USA in Healthy Subjects under Fasting Condition
Bioequivalence Study of Fluconazole 150 mg Capsules Manufactured by PT Interbat in Comparison with Diflucan® 150 mg Capsules Manufactured by PT Pfizer Indonesia, Jakarta, Indonesia, Under the Authority of Pfizer Inc., New York, N.Y., USA in Healthy Subjects under Fasting Condition
Interventional
Fluconazole 150 mg Capsules
15
 

Inclusion Criteria:

Subjects had read the subject information and were able to give written informed consent for participation in the study and comply with the study protocol/procedures, Subjects were healthy male and female, Subjects’ age ranges from 18 – 55 years, Subjects’ body mass index between 18 – 25 kg/m2, Subjects had a normal electrocardiogram, Subjects had resting vital signs (after 10 – 15 minutes of resting) were within the following ranges: Systolic blood pressure: 90 – 129 mmHg, Diastolic blood pressure: 60 – 84 mmHg, Pulse/Heart rate: 60 – 100 beats per minute, Subjects had no significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

those who were pregnant and/or nursing condition, those with a history of hypersensitivity or contraindication to fluconazole, or allied drugs, 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/intestinal surgery, renal insufficiency, hepatic dysfunction or any cardiovascular disease, those who had history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period, those who had 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 participated in any clinical study within the past 90 days prior to the study, those who donated or lost 300 ml (or more) of blood within 3 months prior to the study, those who were smoking more than 10 cigarettes a day, those who have had history or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea with in the last 14 days, those who were positive result for 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 are unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access
 
KET-1728/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
855/STD/PML/2024
Nabila Mudin S