BIOEQUIVALENCE STUDY OF FLUOXETINE HCL 20 MG (FORANSI® 20) CAPSULES MANUFACTURED BY PT GRACIA PHARMINDO IN COMPARISON WITH PROZAC® 20 MG CAPSULES MANUFACTURED BY PATHEON FRANCE, S.A.S FOR ELI LILLY AND COMPANY, INDIANAPOLIS, USA, REGISTERED BY PT PYRIDAM FARMA TBK, CIANJUR, INDONESIA

Tahapan Penelitian : Initial
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-61WKWD99
Tanggal Input Registry : 20-05-2025

09-02-2025
Bioquivalence is concluded if the 90% confidence interval if the Test/Reference Gemoetric Means Ratio (GMR) is in the range of 80.00 - 125.00% with 90% power confidencce interval and 0.05 alpha, AUC72 and Cmax
 
BIOEQUIVALENCE STUDY OF FLUOXETINE HCL 20 MG (FORANSI® 20) CAPSULES MANUFACTURED BY PT GRACIA PHARMINDO IN COMPARISON WITH PROZAC® 20 MG CAPSULES MANUFACTURED BY PATHEON FRANCE, S.A.S FOR ELI LILLY AND COMPANY, INDIANAPOLIS, USA, REGISTERED BY PT PYRIDAM FARMA TBK, CIANJUR, INDONESIA
BIOEQUIVALENCE STUDY OF FLUOXETINE HCL 20 MG (FORANSI® 20) CAPSULES MANUFACTURED BY PT GRACIA PHARMINDO IN COMPARISON WITH PROZAC® 20 MG CAPSULES MANUFACTURED BY PATHEON FRANCE, S.A.S FOR ELI LILLY AND COMPANY, INDIANAPOLIS, USA, REGISTERED BY PT PYRIDAM FARMA TBK, CIANJUR, INDONESIA
Interventional
Not Specified
16
 

Inclusion Criteria:

Have read the subject information and able to give written informed consent for participation in the study and comply with the study protocol/ procedures ; Healthy male and female ; Age between 15 - 55 years ; Body Mass Index (BMI) between 18-25 kg/m2 ; Having a normal electrocardiogram; Resting vital sign (after 10 - 15 minutes of resting) are within the following range systolic blood pressure (90-129 mmHg), diastolic blood pressure (60-84 mmHg), pulse/ heart rate (60-100 beats per minutes) based on ESC guideline for Hypertension 2018 ; Have no significant disease or clinically significant abnorma laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion Criteria:

Pregnant and/or nursing woman ; Having history of contraindication or hypersensitivity to fluoxetine, 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 ; Having 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 ; Having history or presence of any coagulation disorder or clinically significant hematology abnormalities ; Disagree to use non-hormonal contraceptives methods (condom) before any intercourse with their spouse within study period ; 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 two weeks prior to the drug administration day ; Participated in any clinical study within the past 90 days prior to the study ; Donated or lost 300 mL (or more) of blood within 3 months prior to the study ; Smoker ; History or present of sore throat, fever (with temperature more than 37°C), cough, cold, anosmia/loss of smell, or dyspnea within the last 14 days ; Positive to HIV, HBsAg, and HCV tests (to be kept confidential) ; History of drug or alcohol abuse within 12 months prior to screening for this study ; Unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow up visits, poor venous access.
 
KET-1842/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
PT. Gracia Pharmindo