Bioequivalence study of fluoxetine 20 mg capsule produced by PT Mersifarma Tirmaku Mercusana in comparison with the comparator drug (Prozac® 20 mg Capsule produced by Patheon France, S.A.S for Eli Lilly and Company, Indianapolis USA, registered by PT Pyridam Farma Tbk, Cianjur, Indonesia) when administered under fasting condition in healthy subjects.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Not Specified
No Registry
INA-4PSMALG1
Tanggal Input Registry : 16-04-2025

25-04-2025
Not Specified
 
Bioequivalence study of fluoxetine 20 mg capsule produced by PT Mersifarma Tirmaku Mercusana in comparison with the comparator drug (Prozac® 20 mg Capsule produced by Patheon France, S.A.S for Eli Lilly and Company, Indianapolis USA, registered by PT Pyridam Farma Tbk, Cianjur, Indonesia) when administered under fasting condition in healthy subjects.
Bioequivalence study of fluoxetine 20 mg capsule produced by PT Mersifarma Tirmaku Mercusana in comparison with the comparator drug (Prozac® 20 mg Capsule produced by Patheon France, S.A.S for Eli Lilly and Company, Indianapolis USA, registered by PT Pyridam Farma Tbk, Cianjur, Indonesia) when administered under fasting condition in healthy subjects.
Interventional
Fluoxetine HCl
5
 

Inclusion Criteria:

Able to participate, communicate well with the investigators and would provide written informed consent to participate in the study, Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening and could be considered healthy based on the evaluation,Aged 18 – 55 years inclusive,Preferably non-smokers or smoke less than 10 cigarettes each day, Body mass index within 18 to 25 kg/m2, Vital signs (after 10 minutes rest) were within the following ranges:Systolic blood pressure : 100 – 129 mmHg;Diastolic blood pressure : 60 – 84 mmHg; Pulse rate : 60 – 100 bpm, Willing to practice abstention or non-hormonal contraception during the study.

Exclusion Criteria:

History of allergy or hypersensitivity or contraindication to fluoxetine or allied drug, Pregnant or lactating female (urinary pregnancy test will be applied to female subjects at screening and before taking the drug study), Any major illness in the past 90 days or clinically significant ongoing chronic medical illness, Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc, Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV, Clinically significant hematology abnormalities, Clinically significant electrocardiogram (ECG) abnormalities, Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery, Past history of anaphylaxis or angioedema, History of seizure, epilepsy, or any kind of neurological disorders, . History of drug or alcohol abuse within 12 months prior to screening for this study, Participation in any clinical trial within the past 90 days calculated from the last visit to this study’s first dosing day, History of any bleeding or coagulative disorders, Presence of difficulty in accessibility of veins in left or right arm during screening, A donation or significant blood loss within 90 days before this study’s first dosing day, Intake of any prescription, non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day.
 
No. KET-229/UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
NA
Apt. Anasari Hasema Kadar Hastuti, S.Farm