Bioequivalence Study of 150 mg Fluconazole Capsules Manufactured by PT. Kalbe Farma Tbk in Comparison with 150 mg Diflucan® Capsules Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, under the authority of Pfizer Inc., New York, N.Y., USA.

Tahapan Penelitian : Rampung
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-BC2YXAW
Tanggal Input Registry : 20-01-2023

04-03-2022
90% Confidence Interval, Cmax and AUCt
N.A
 
Bioequivalence Study of 150 mg Fluconazole Capsules Manufactured by PT. Kalbe Farma Tbk in Comparison with 150 mg Diflucan® Capsules Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, under the authority of Pfizer Inc., New York, N.Y., USA.
Bioequivalence Study of 150 mg Fluconazole Capsules Manufactured by PT. Kalbe Farma Tbk in Comparison with 150 mg Diflucan® Capsules Manufactured by PT. Pfizer Indonesia, Jakarta, Indonesia, under the authority of Pfizer Inc., New York, N.Y., USA.
Eksperimental
Subjects were given a single dose of 150 mg fluconazole of either formulation (test or reference) with 240 mL of water
14
 

Inclusion Criteria:

The inclusion criteria’s were healthy male or female subjects who/with: - had read the subject information and signed informed consent documents - 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 protection (condom) before any intercourse with their spouse throughout the study

Exclusion Criteria:

The subjects’ exclusion criteria’s for the study: - those who were pregnant and/or nursing women. - those with history of contraindication or hypersensitivity to fluconazole or other antifungal 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 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 (
 
KET-1231/UN2.F1/ETIK/PPM.00.02/2021
N.A
RG.01.02.321.02.22.00701/UB
516/STD/PML/2019
Nabila MS