Bioequivalence study of Fluvoxamine Maleate 100 mg fil coated tablet produced by PT Yarindo Farmatama in comparison with Luvox® (Fluvoxamine Maleate 100 mg) film coated tablet manufactured by Mylan Laboratories SAS, Maillard, France, imported by PT Abbott Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT Yarindo Farmatama
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-6WZBX6R8
Tanggal Input Registry : 14-05-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 19-02-2025 |
| Outcome Primer | AUCt and Cmax |
| Outcome Skunder | AUCinf, Tmax, half-life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Fluvoxamine Maleate 100 mg fil coated tablet produced by PT Yarindo Farmatama in comparison with Luvox® (Fluvoxamine Maleate 100 mg) film coated tablet manufactured by Mylan Laboratories SAS, Maillard, France, imported by PT Abbott Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence study of Fluvoxamine Maleate 100 mg film coated tablet produced by PT Yarindo Farmatama in comparison with Luvox® (Fluvoxamine Maleate 100 mg) film coated tablet manufactured by Mylan Laboratories SAS, Maillard, France, imported by PT Abbott Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Test drug: Fluvoxamine Maleate 100 mg film coated tablet |
| Jumlah Subyek Penelitian | 16 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Willing to sign the informed consent; Age 18 – 55 years; Body mass index between 18 – 25 kg/m2; Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 6080 mmHg), heart rate 60 – 100 beats per minute (as assessed through both pulse examination and ECG test results), respiration rate 12-20 x/minutes, body temperatureExclusion Criteria: Contraindicated and/or has history of hypersensitivity to Fluvoxamine or related drug, With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g., chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, or cardiovascular disease; Show abnormal result or not within the acceptance range in the electrocardiography (ECG) test result; Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the study; Participated in any clinical study within 3 months prior to the dosing day; Donated or lost 300 mL (or more) of blood within 3 months prior to the dosing day; Smoke more than 9 sticks of cigarettes a day; Have any bleeding or coagulation disorder; With the history of alcohol and drug abuse; Indicate the positive result on test for HbsAg, Anti-HCV and anti-HIV; Pregnant or lactating female (urinary pregnancy test applied to female subjects at screening and before taking the study drug). |
| Administrative Information | |
| Nomor Persetujuan Etik | No. KET - 36/UN2.F1/ETIK/PPM.00.02/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Protocol No. 222/FORM/OMF/2024 Report No. 172/RPT/OMF/2025 |
| Contact Person | apt. Tasha Yuliandra, M.Sc |