BIOEQUIVALENCE STUDY OF PREGABALIN 75 MG CAPSULES MANUFACTURED BY PT. MAHAKAM BETA FARMA IN COMPARISON WITH LYRICA® 75 MG CAPSULES MANUFACTURED BY PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, GERMANY, IMPORTED BY PT. PFIZER INDONESIA, JAKARTA
Tahapan Penelitian : Complete
Sponsor:
PT. Mahakam Beta Farma
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-F31CX8K
Tanggal Input Registry : 13-02-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 24-08-2022 |
| Outcome Primer | The results of this study showed that Pregabalin 75 mg capsules manufactured by PT. Mahakam Beta Farma was bioequivalent towards its reference product, Lyrica® 75 mg capsules manufactured by Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany, imported by PT. Pfizer Indonesia, Jakarta. |
| Outcome Skunder | - |
| Descriptive Information | |
| Judul Penelitian Popular | BIOEQUIVALENCE STUDY OF PREGABALIN 75 MG CAPSULES MANUFACTURED BY PT. MAHAKAM BETA FARMA IN COMPARISON WITH LYRICA® 75 MG CAPSULES MANUFACTURED BY PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, GERMANY, IMPORTED BY PT. PFIZER INDONESIA, JAKARTA |
| Judul Penelitian Ilmiah | BIOEQUIVALENCE STUDY OF PREGABALIN 75 MG CAPSULES MANUFACTURED BY PT. MAHAKAM BETA FARMA IN COMPARISON WITH LYRICA® 75 MG CAPSULES MANUFACTURED BY PFIZER MANUFACTURING DEUTSCHLAND GMBH, FREIBURG, GERMANY, IMPORTED BY PT. PFIZER INDONESIA, JAKARTA |
| Jenis Penelitian | Interventional |
| Intervensi | Penelitian ini dilakukan dengan memberikan kepada masing-masing subjek uji BE obat inovator dan obat uji dengan kandungan yang sama. Obat uji: Kapsul Pregabalin 75 mg produksi PT. Mahakam Beta Farma. Obat inovator: Kapsul Lyrica® produksi Pfizer Deutschland, Gmbh, Freiburg, Germany diimpor oleh PT. Pfizer Indonesia, Jakarta |
| Jumlah Subyek Penelitian | 17 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: - healthy male or female subjects - had read the subject information and signed informed consent documents - were age between 18 to 55 years - had body mass index between 18 to 25 kg/m2 - had a normal electrocardiogram - had normal blood pressure (systolic was ranged between 90 to 120 mmHg and diastolic was ranged between 60 to 80 mmHg) - had normal heart rate (ranged between 60 to 100 bpm) - had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. - accepted to use protection (condom) during intercourse with their spouse throughout the studyExclusion Criteria: - those who were pregnant and/or nursing women. - those with a history of hypersensitivity to pregabalin or other anticonvulsant or other ingredients in the study products or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction - those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease,diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease. - those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities. - those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day. - those who had participated in any clinical study within 3 months prior to the study ( |
| Administrative Information | |
| Nomor Persetujuan Etik | S-577/UN2.F1/ETIK/PPM.00.02/2022 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | 678/STD/PML/2022 |
| Contact Person | Suharti K. Suherman, MD, SpFK (K) |