BIOEQUIVALENCE STUDY OF FARSORBID® 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH CEDOCARD 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET MANUFACTURED BY PT DARYA-VARIA LABORATORIA TBK, UNDER LICENSE OF TAKEDA NETHERLAND B.V.
Tahapan Penelitian : Complete
PT Pratapa Nirmala
PT Omega Medika Farma Laboratori
Tanggal Input Registry : 30-03-2023
|Tanggal Antisipasi Studi||09-11-2022|
|Outcome Primer||AUC0-t and Cmax|
|Outcome Skunder||AUC0-∞, T1/2, Tmax|
|Judul Penelitian Popular||BIOEQUIVALENCE STUDY OF FARSORBID® 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH CEDOCARD 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET MANUFACTURED BY PT DARYA-VARIA LABORATORIA TBK, UNDER LICENSE OF TAKEDA NETHERLAND B.V.|
|Judul Penelitian Ilmiah||BIOEQUIVALENCE STUDY OF FARSORBID® 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET PRODUCED BY PT PRATAPA NIRMALA IN COMPARISON WITH CEDOCARD 5 (5 MG ISOSORBIDE DINITRATE) SUBLINGUAL TABLET MANUFACTURED BY PT DARYA-VARIA LABORATORIA TBK, UNDER LICENSE OF TAKEDA NETHERLAND B.V.|
|Intervensi||The reference drug was the market available Cedocard® 5 (5 mg Isosorbide Dinitrate) sublingual tablet manufactured by PT Darya-Varia Laboratoria Tbk., under license of Takeda Netherland B.V., batch number LX1A057, manufacturing date on November 2021; expiration date on November 2024. The test drug was Farsorbid® 5 (5 mg Isosorbide Dinitrate) sublingual tablet produced by PT. Pratapa Nirmala, batch number FG 0801; manufacturing date on July 2021; expiration date on July 2023. subjects took 1 dose of ISDN products of either formulation (reference or test) as per randomization scheme in sitting position as scheduled. Subject took a glass of water (240 mL) 10-15 minutes before drug administration. After that subject was asked to put the tablet under the tongue and wait until the drug dissolved.|
|Jumlah Subyek Penelitian||16|
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 sugar and urinalysis; history of disease, and physical examination), - Show normal result or within the acceptance range (not clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test result.
Exclusion Criteria:- Contraindicated and/or has history of hypersensitivity to ISDN 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, - Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the dosing day, - Participated in any clinical study within 3 months prior the study, - Donated or lost 300 mL (or more) of blood within 3 months prior the study, - Smoke more than 10 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 - If the study is conducted in Covid-19 pandemic situation, the exclusions criteria below must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days, b. With history or present sore throat, fever (temperature more than 37oC) or short of breath within last 14 days, c. Positive to Covid-19 antigen rapid test.
|Nomor Persetujuan Etik||KET-1047/UN2.F1/ETIK/PPM.00.02/2022|
|Nomor Persetujuan Material Transfer Agreement|
|Nomor Persetujuan Pelaksanaan Uji Klinik|
|Other Study ID Numbers||158/FORM/OMF/2022|
|Contact Person||apt. Haranissa Dea Oktania, S.Farm.|