Bioequivalence Study of 50 mg Diclofenac Sodium Enteric Coated Tablets, Manufactured by PT First Medipharma (Diclofenac Sodium) in Comparison with the Innovator’s Enteric Coated Tablets (Voltaren®), Manufactured by PT Novartis Indonesia, Jakarta, Indonesia
Tahapan Penelitian : Complete
Sponsor:
PT First Medipharma
Mitra Pelaksana:
Econolab
No Registry
INA-HRTY37H
Tanggal Input Registry : 07-11-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 27-08-2023 |
| Outcome Primer | AUC0-t and Cmax |
| Outcome Skunder | AUC0-inf, Tmax, T1/2 |
| Descriptive Information | |
| Judul Penelitian Popular | Bioequivalence Study of 50 mg Diclofenac Sodium Enteric Coated Tablets, Manufactured by PT First Medipharma (Diclofenac Sodium) in Comparison with the Innovator’s Enteric Coated Tablets (Voltaren®), Manufactured by PT Novartis Indonesia, Jakarta, Indonesia |
| Judul Penelitian Ilmiah | Bioequivalence Study of 50 mg Diclofenac Sodium Enteric Coated Tablets, Manufactured by PT First Medipharma (Diclofenac Sodium) in Comparison with the Innovator’s Enteric Coated Tablets (Voltaren®), Manufactured by PT Novartis Indonesia, Jakarta, Indonesia |
| Jenis Penelitian | Interventional |
| Intervensi | Single dose of 50 mg Diclofenac Sodium Enteric Coated Tablet manufactured by PT First Medipharma |
| Jumlah Subyek Penelitian | 26 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Able to participate, communicate well with investigators, and agree to sign the informed consent; Willing to use contraception (condoms) when having intercourse with spouse during the study; Healthy male/female subjects, as determined by the medical screening assessments, and did not show any symptoms of Covid-19; Aged between 18 – 55 years; Body mass index (BMI) within the range of 18 – 25 kg/m²; Have received the complete primary SARS-CoV-2 vaccine and at least the first booster; Normal blood pressure (systolic 100 – 120 mmHg; diastolic 60 – 80 mmHg); normal pulse rate (60 – 90 bpm); Normal electrocardiogram (ECG); Clinical laboratory tests result within the normal range.Exclusion Criteria: Pregnant or lactating women (urinary pregnancy test was done to female subject during screening and before taking the test or innovator drug); Known hypersensitivity or contraindication to the study drug; Intake of any prescription drug or non-prescription drug/food supplement/herbal medicine within seven (7) days of this study’s first dosing day; History of any bleeding or coagulation disorders; Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g., gastrointestinal diseases including gastric or duodenal ulcers or a history of gastric surgery; A donation or loss of 300 mL (or more) of blood within three (3) months before this study’s first dosing day; A positive Hepatitis B surface antigen (HBsAg), HCV, HIV test results; History of drug or alcohol abuse within 12 months prior to this study; Heavy smoker (more than ten (10) cigarettes a day); Had clinically significant bleeding within three (3) months prior to the study; Participated in a previous study within three (3) months of this study’s first dosing day. |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-1458/UN2.F1/ETIK/PPM.00.02/2020 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | PRO-252/20/ECL |
| Contact Person | Ni Made Dwi Wulandari |