Bioequivalence study of Atranac 50 (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Corsa Industries in comparison with Voltaren® (50 mg Diclofenac Sodium) enteric coated tablet manufactured by PT Novartis Indonesia, under supervision of Novartis Pharma AG.
Tahapan Penelitian : Complete
Sponsor:
PT Corsa Industries
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-2SR7KNB
Tanggal Input Registry : 22-09-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 14-03-2023 |
| Outcome Primer | AUCt and Cmax |
| Outcome Skunder | AUCinf, tmax, half-life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Atranac 50 (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Corsa Industries in comparison with Voltaren® (50 mg Diclofenac Sodium) enteric coated tablet manufactured by PT Novartis Indonesia, under supervision of Novartis Pharma AG. |
| Judul Penelitian Ilmiah | Bioequivalence study of Atranac 50 (50 mg Diclofenac Sodium) enteric coated tablet produced by PT Corsa Industries in comparison with Voltaren® (50 mg Diclofenac Sodium) enteric coated tablet manufactured by PT Novartis Indonesia, under supervision of Novartis Pharma AG. |
| Jenis Penelitian | Interventional |
| Intervensi | The reference drug was Voltaren® (50 mg Diclofenac Sodium) enteric coated tablet manufactured by PT Novartis Indonesia under supervision of Novartis Pharma AG. The test drug was Atranac 50 (50 mg Diclofenac Sodium enteric coated tablet produced by PT Corsa Industries. In the morning of the sampling as scheduled, subjects was given one dose of Diclofenac Sodium products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position. |
| Jumlah Subyek Penelitian | 24 |
| 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 Diclofenac Sodium 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. |
| Administrative Information | |
| Nomor Persetujuan Etik | 136/UN2.F1/ETIK/PPM.00.02/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | apt. Noviyanto, S.Farm |