Bioequivalence Study of 0,375 mg Pramipexole Dihydrochloride Monohydrate (Pramivex® XR) Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Sifrol® ER 0,375 mg Extended Release Tablets Manufactured by Rottendorf Pharma GMBH, Germany for Boehringer Ingelheim International GmbH & Co.KG, Germany, Imported by PT. Boehringer Ingelheim Indonesia
| 1. Background | |
|---|---|
| Registration Number | INA-6BWA5XEN |
| Date of registry approval | 05-06-2025 |
| Registration Date | 05-06-2025 |
| Secondary identifiers | No |
| Name of issuing authority (for example protocol number, other registries, etc) | |
| Secondary identifier number | |
| Scientific study title | Bioequivalence Study of 0,375 mg Pramipexole Dihydrochloride Monohydrate (Pramivex® XR) Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Sifrol® ER 0,375 mg Extended Release Tablets Manufactured by Rottendorf Pharma GMBH, Germany for Boehringer Ingelheim International GmbH & Co.KG, Germany, Imported by PT. Boehringer Ingelheim Indonesia |
| Public (popular study title) | Bioequivalence Study of 0,375 mg Pramipexole Dihydrochloride Monohydrate (Pramivex® XR) Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories in Comparison with Sifrol® ER 0,375 mg Extended Release Tablets Manufactured by Rottendorf Pharma GMBH, Germany for Boehringer Ingelheim International GmbH & Co.KG, Germany, Imported by PT. Boehringer Ingelheim Indonesia |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT. Novell Pharmaceutical Laboratories |
| Source(s) of monetary or material support | Sponsor : PT Novell Pharmaceutical Laboratories |
| Other partners | PT Clinisindo Laboratories |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Prof. Dr. apt Yahdiana Harahap, MS |
| City | Jakarta Selatan |
| Country | Indonesia |
| Principal investigator's affiliation | PT Clinisindo Laboratories |
| Principal Investigator's email address | Yahdiana03@yahoo.com |
| Public Queries | |
| Contact person name for public queries | Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com |
| Address for public queries | Apt. Windy Lusthom, S.Si – Study Director PT Clinisindo Laboratories Jl. Ulujami Raya No.12, Pesanggrahan, Jakarta Selatan 12250, Indonesia Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com |
| City | Jakarta Selatan |
| Country | Indonesia |
| ZIP | 12250 |
| Affiliation for public queries | PT Clinisindo Laboratories |
| Email address for public queries | Apt. Windy Lusthom, S.Si – Study Director e-Mail: Windy.Lusthom@clinisindo.com |
| Phone number for public queries | (62-21) 73889918 |
| Scientific Queries | |
| Name of Contact for scientific queries | Apt. Windy Lusthom, S.Si – Study Director Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com |
| Address for scientific queries | Apt. Windy Lusthom, S.Si – Study Director PT Clinisindo Laboratories Jl. Ulujami Raya No.12, Pesanggrahan, Jakarta Selatan 12250, Indonesia Telp : (62-21) 73889918, e-Mail: Windy.Lusthom@clinisindo.com |
| City | Jakarta Selatan |
| Country | Indonesia |
| ZIP | 12250 |
| Affiliation of scientific queries contact | PT Clinisindo Laboratories |
| Email address for scientific queries | e-Mail: Windy.Lusthom@clinisindo.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | KET-141/UN2.F1/ETIK/PPM.00.02/2023 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia –RSUPN Dr. Cipto Mangunkusumo |
| Date of Ethic approval | 30-01-2023 |
| Contact details of Ethic Committee (phone, email, and office) | Komite Etik FKUI/RSCM Jl. Salemba 6, Jakarta Pusat Whatsapp : 0856-8701-608 Telp. 021 315 7008 E-mail :ec_fkui@yahoo.com |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.02.321.08.24.02864/UB |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | PT Clinisindo Laboratories |
| Recruitment status | Complete |
| Date of first enrollment | 20-09-2024 |
| Targeted Sample size | 00021 - |
| Number of enrolled participants | 23 |
| Date of study completion (last participant, last visit) | 03-10-2024 |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | Study in healthy human volunteers |
| Purpose of the study | Bioequivalence study |
| Study type | Interventional |
| Interventional Study category | Bioequivalence study |
| Method of allocation | |
| Description of the allocation concealment mechanism and sequence generation | |
| Masking | |
| Study intervention (study arm) | Pramipexole Dihydrochloride Monohydrate (Pramivex® XR) Extended Release Tablets Produced by PT. Novell Pharmaceutical Laboratories |
| Control intervention (control arm) | Sifrol® ER 0,375 mg Extended Release Tablets Manufactured by Rottendorf Pharma GMBH, Germany for Boehringer Ingelheim International GmbH & Co.KG, Germany, Imported by PT. Boehringer Ingelheim Indonesia |
| Intervention assignment | Crossover |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Not specified |
| Minimum age | 18 |
| Maximum age | 55 |
| Inclusion criteria | 1. Memberikan persetujuan tertulis.
2. Subjek sehat, kedua jenis kelamin, berusia antara 18 hingga 55 tahun. 3. Berat badan dengan kisaran normal sesuai dengan nilai normal yang diterima untuk Indeks Massa Tubuh (IMT = 18-25 kg/m2). 4. Nilai normal tekanan darah yang diterima (tekanan darah sistolik ≤129 mmHg dan ≥100 mmHg, tekanan darah diastolik ≤84 mmHg dan ≥70 mmHg) dan denyut jantung (60-90 bpm).* 5. Riwayat medis dan pemeriksaan fisik yang dapat diterima. 6. Nilai hematologi normal meliputi: hemoglobin, hematokrit, eritrosit, leukosit, nilai sel darah merah (MC), diferensial leukosit, jumlah trombosit, dan laju sedimentasi eritrosit (LED).* 7. Pemeriksaan laboratorium normal meliputi: sGPT, sGOT, alkali fosfatase, bilirubin total, protein total, albumin, globulin, glukosa darah, nitrogen urea darah, ureum, kreatinin.* 8. Hasil urinalisis normal meliputi: warna, kejernihan, berat jenis, pH, leukosit esterase, nitrit, glukosa, keton, urobilinogen, bilirubin, sedimen darah dan urin (sel, silinder, dan bakteri).* 9. Fungsi kardiovaskular normal dibuktikan dengan hasil elektrokardiogram (EKG). 10. Hasil negatif untuk pemeriksaan serologis antigen hepatitis B (HBsAg), Hepatitis C (anti HCV), HIV (anti HIV). 11. Hasil negatif untuk tes penyalahgunaan obat amfetamin, metamfetamin, morfin, mariyuana/tetrahidrokanabinol (THC), dan benzodiazepin. 12. Hasil negatif untuk tes kehamilan (akan dilakukan untuk subjek perempuan saat skrining, sebelum periode I dan sebelum periode II penelitian). Catatan: Penyelidik klinis mungkin memasukkan subjek yang memiliki nilai di luar rentang yang diterima, jika menurut pendapatnya, nilai ini tidak signifikan secara klinis |
| Exclusion criteria | 1. Perokok. Jika perlu, perokok ringan (≤5 batang rokok/hari) dapat diterima.
2. Wanita hamil atau ibu menyusui. 3. Memiliki riwayat penyakit hati, kardiovaskular, gastrointestinal atau ginjal. 4. Memiliki riwayat atau kondisi hipotensi postural/ortostatik. 5. Memiliki riwayat atau kondisi halusinasi, perilaku abnormal dan gangguan psikotik. 6. Memiliki riwayat atau kondisi diskinesia. 7. Memiliki riwayat atau kondisi distonia. 8. Memiliki riwayat atau kondisi rabdomiolisis. 9. Memiliki riwayat atau kondisi melanoma. 10. Memiliki riwayat atau kondisi augmentasi. 11. Hipersensitif terhadap pramipexole dihydrochloride monohydrate atau obat serupa. 12. Riwayat penyalahgunaan alkohol, obat-obatan dalam waktu 12 bulan sebelum skrining untuk penelitian ini. 13. Menerima pengobatan lain dalam waktu empat belas hari sebelum dimulainya penelitian. 14. Berpartisipasi dalam penelitian klinis dalam waktu 3 bulan setelah tanggal penyelesaian. 15. Donor atau kehilangan lebih dari 300 mL darah dalam waktu 3 bulan sebelum penyaringan penelitian |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | AUC0-t , AUC0-inf , Cmax |
| Metric/method of measurement | Statistical analysis with Anova using Microsoft® Excel 2010, SAS® version 9.1 |
| Timepoint(s) of measurement | pre dose, at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 36, 48 and 72 hours after drug administration |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | tmax, t1/2 |
| Metric/method of measurement (SO1) | Statistical analysis with Anova using Microsoft® Excel 2010, SAS® version 9.1 |
| Timepoint(s) of measurement (SO1) | pre dose, at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 24, 36, 48 and 72 hours after drug administration |
| 9. Study Results | |
| Brief summary of study results | There were no statistically significant difference detected using ANOVA for log-transformed
data of AUC0-t, AUC0-∞, and Cmax where the 90% confidence intervals (CI) were included into interval range of 80.00-125.00%. In the same way, the individual t1/2 and tmax difference were not statistically different between the two formulations detected using Wilcoxon signed rank test without logarithmic transformation. Based on these results, it can be concluded that a single dose of 0.375 mg Pramipexole Dihydrochloride Monohydrate (Pramivex® XR) extended release tablets produced by PT. Novell Pharmaceutical Laboratories demonstrate bioequivalence in terms of rate and extent of absorption to a single dose of Sifrol® ER 0.375 mg extended release tablets manufactured by Rottendorf Pharma GmbH, Germany for Boehringer Ingelheim International GmbH & Co.KG, Germany, imported by PT. Boehringer Ingelheim Indonesia. |
| Date of results summaries | 03-01-2025 |
| Participant flow | 35 Subjek mengikuti kegiatan skrining
23 Subjek enrolled 21 subjek mengikuti kegiatan sampling |
| Baseline characteristic | |
| Adverse events | Bradikardia, Hipotensi |
| Outcome measures | The 90% Confidence Interval (CI) with α = 5.00% for AUC0-inf, AUC0-24h and Cmax were within the range of 80.00 - 125.00% interval |
| 10. Publication | |
| URL hyperlink(s) related to results and publications | |
| IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD)) | No |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | Not Specified |