Bioequivalence study of Tracetate (Megestrol Acetate 160 mg) tablet produced by PT Pratapa Nirmala in comparison with Megace® 160 mg (Megestrol Acetate 160 mg) tablet manufactured by Haupt Pharma Amareg GmbH, Regensburg, Germany, under marketing authorization holder of Bausch Health Ireland Limited
Tahapan Penelitian : Complete
Sponsor:
PT Pratapa Nirmala
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-7FLZR8S
Tanggal Input Registry : 11-09-2024
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 06-07-2024 |
| Outcome Primer | AUCt and Cmax |
| Outcome Skunder | AUCinf, tmax, half-life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Tracetate (Megestrol Acetate 160 mg) tablet produced by PT Pratapa Nirmala in comparison with Megace® 160 mg (Megestrol Acetate 160 mg) tablet manufactured by Haupt Pharma Amareg GmbH, Regensburg, Germany, under marketing authorization holder of Bausch Health Ireland Limited |
| Judul Penelitian Ilmiah | Bioequivalence study of Tracetate (Megestrol Acetate 160 mg) tablet produced by PT Pratapa Nirmala in comparison with Megace® 160 mg (Megestrol Acetate 160 mg) tablet manufactured by Haupt Pharma Amareg GmbH, Regensburg, Germany, under marketing authorization holder of Bausch Health Ireland Limited |
| Jenis Penelitian | Interventional |
| Intervensi | Test Drug: Tracetate (Megestrol Acetate 160 mg) tablet PT Pratapa Nirmala |
| Jumlah Subyek Penelitian | 20 |
| 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 60-80 mmHg), heart rate 60 – 90 beats per minute; Healthy male (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood glucose, and urinalysis; history of disease, and physical examination)Exclusion Criteria: Contraindicated and/or has history of hypersensitivity to Megestrol Acetate 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 (clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test results, Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 14 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; Indicate the positive result on test for HbsAg, Anti-HCV, and anti-HIV; With the history of alcohol and drug abuse; To reduce the risk of Covid-19 transmission, the exclusions criteria below must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days; With history or present sore throat, fever (temperature more than 37°C) or short of breath within last 14 days; Positive to Covid-19 antigen rapid test, for those who do not yet receive a complete primary vaccination against Covid-19 and at least the first booster. |
| Administrative Information | |
| Nomor Persetujuan Etik | No. KET-532/ UN2.F1/ETIK/PPM.00.02/2024 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | Protocol No. 180/FORM/OMF/2023 ver 01 Report No. 152/RPT/OMF/2024 ver 00 |
| Contact Person | apt. Tasha Yuliandra, M.Sc |