Bioequivalence study of Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala in comparison with Zorvolex 35 capsule produced by Catalent CTS, LLC United States for Iroko Pharmaceuticals Inc., British Virgin Islands.
Tahapan Penelitian : Complete
Sponsor:
PT Pratapa Nirmala
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-PGABK49
Tanggal Input Registry : 24-11-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 10-04-2021 |
| Outcome Primer | AUCt and Cmax |
| Outcome Skunder | AUCinf, tmax, half-life |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence study of Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala in comparison with Zorvolex 35 capsule produced by Catalent CTS, LLC United States for Iroko Pharmaceuticals Inc., British Virgin Islands. |
| Judul Penelitian Ilmiah | Bioequivalence study of Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala in comparison with Zorvolex 35 capsule produced by Catalent CTS, LLC United States for Iroko Pharmaceuticals Inc., British Virgin Islands. |
| Jenis Penelitian | Interventional |
| Intervensi | The reference drug was the market available Zorvolex 35 capsule, batch number MF 1391; manufacturing date June 2019; expiration date June 2021 The test drug was Diclofenac acid 35 mg capsule produced by PT. Pratapa Nirmala, batch number LK 1831; manufacturing date November 2020; expiration date November 2022. In the morning of the sampling as scheduled, subjects were given one dose of Diclofenac Acid products of either formulation (reference or test), as per randomization scheme with 240 mL of water in sitting position. |
| 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 60-80 mmHg), heart rate 60 – 90 beats per minute, Healthy male/female (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),Exclusion Criteria: Contraindicated and/or has history of hypersensitivity to Diclofenac acid 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, pregnant or lactating women, female subjects who give positive pregnancy test at pre-study examination, If the study is conducted in Covid-19 pandemic situation, the exclusions criteria below must be applied: a. With history of travelling to another city within last 14 days, b. With history of direct contact with a Covid-19 positive person in the subject neighborhood, 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 | KET-192/UN2.F1/ETIK/PPM.00.02/2021 |
| 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 |