Bioequivalence study of Rosuvastatin 10 mg Film Coated Tablet, Noterol manufactured by PT Konimex in comparison with Rosuvastatin 10 mg Film Coated Tablet, Crestor® manufactured by IPR Pharmaceuticals Inc. Puerto Rico; for AstraZeneca UK Limited; packed and released by AstraZeneca Pharmaceuticals Co. Ltd China; imported by PT Astrazeneca Indonesia
| 1. Background | |
|---|---|
| Registration Number | INA-HYHY182 |
| Date of registry approval | 29-10-2024 |
| Registration Date | 02-08-2023 |
| Secondary identifiers | No |
| Name of issuing authority (for example protocol number, other registries, etc) | |
| Secondary identifier number | |
| Scientific study title | Bioequivalence study of Rosuvastatin 10 mg Film Coated Tablet, Noterol manufactured by PT Konimex in comparison with Rosuvastatin 10 mg Film Coated Tablet, Crestor® manufactured by IPR Pharmaceuticals Inc. Puerto Rico; for AstraZeneca UK Limited; packed and released by AstraZeneca Pharmaceuticals Co. Ltd China; imported by PT Astrazeneca Indonesia |
| Public (popular study title) | Bioequivalence study of Rosuvastatin 10 mg Film Coated Tablet, Noterol manufactured by PT Konimex in comparison with Rosuvastatin 10 mg Film Coated Tablet, Crestor® manufactured by IPR Pharmaceuticals Inc. Puerto Rico; for AstraZeneca UK Limited; packed and released by AstraZeneca Pharmaceuticals Co. Ltd China; imported by PT Astrazeneca Indonesia |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT Konimex |
| Source(s) of monetary or material support | internal company |
| Other partners | PT Biometrik Riset Indonesia |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Dra. Effi Setiawati, Apt., M.Biomed. |
| City | Jawa Barat |
| Country | Indonesia |
| Principal investigator's affiliation | PT. Biometrik Riset Indonesia |
| Principal Investigator's email address | effi@biometrikriset.com |
| Public Queries | |
| Contact person name for public queries | Oktaviani Utami Dewi, S.Si - Ass. Manager QA |
| Address for public queries | PT. Biometrik Riset Indonesia Ruko Brickhouse Jl. Raya Bogor Km 31, No. 52 Unit H dan I, Kelurahan Cisalak, Kecamatan Sukmajaya, Depok, Jawa Barat, 16416 |
| City | Jawa Barat |
| Country | Indonesia |
| ZIP | 16416 |
| Affiliation for public queries | NA |
| Email address for public queries | NA |
| Phone number for public queries | NA |
| Scientific Queries | |
| Name of Contact for scientific queries | apt. Nada Mawaddah, S.Farm. |
| Address for scientific queries | PT. Biometrik Riset Indonesia Ruko Brickhouse Jl. Raya Bogor Km 31, No. 52 Unit H dan I, Kelurahan Cisalak, Kecamatan Sukmajaya, Depok, Jawa Barat, 16416 |
| City | Jawa Barat |
| Country | Indonesia |
| ZIP | 16416 |
| Affiliation of scientific queries contact | PT. Biometrik Riset Indonesia Ruko Brickhouse Jl. Raya Bogor Km 31, No. 52 Unit H dan I, Kelurahan Cisalak, Kecamatan Sukmajaya, Depok, Jawa Barat, 16416 |
| Email address for scientific queries | NA |
| 4. IRB & Regulatory | |
| Ethical Approval number | KET-611/UN2.F1/ETIK/PPM.00.02/2021 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan FKUI - RSUPN Dr. Cipto Mangunkusumo |
| Date of Ethic approval | 14-06-2021 |
| Contact details of Ethic Committee (phone, email, and office) | Jl. Salemba Raya No.6, Jakarta 10430 |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | PPUB10028402300072 |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | Laboratorium Klinik Westerindo |
| Recruitment status | Complete |
| Date of first enrollment | 08-07-2023 |
| Targeted Sample size | 00030 - |
| Number of enrolled participants | 30 |
| Date of study completion (last participant, last visit) | 14-07-2023 |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | hypertension |
| Purpose of the study | Treatment |
| Study type | Interventional |
| Interventional Study category | |
| Method of allocation | |
| Description of the allocation concealment mechanism and sequence generation | |
| Masking | |
| Study intervention (study arm) | |
| Control intervention (control arm) | |
| Intervention assignment | |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Not specified |
| Minimum age | 18 |
| Maximum age | 55 |
| Inclusion criteria | Bersedia berpartisipasi dan setuju menandatangani informed consent, serta mampu berkomunikasi dengan baik dengan Dokter Penanggung Jawab dan Tim Peneliti Biometrik.
Subjek wanita / pria sehat sebagaimana ditentukan oleh penilaian skrining medis. Berumur 18 - 55 tahun. Indeks massa tubuh berkisar antara 18.00 - 25.00 kg / m2 Hasil pengukuran tanda vital setelah istirahat 10 menit: (i). Denyut nadi : 60 - 90 bpm (ii). Laju pernapasan : 12 - 20 x/menit (iii)Tekanan darah sistolik : 110 - 129 mmHg (iv). Tekanan darah diastolik : 60 - 84 mmHg (v). Body Temperature : < 37.5°C Memiliki EKG 12-lead tanpa kelainan yang signifikan. Hasil negatif rapid test Antigen Covid-19 pada saat proses skrining |
| Exclusion criteria | Berpartisipasi dalam penelitian lain dalam waktu 3 (tiga) bulan sebelum hari pertama pemberian obat studi
Wanita hamil atau menyusui (tes kehamilan urin akan dilakukan pada hari skrining dan sebelum studi pemberian obat pada setiap periode). Perokok atau merokok lebih dari 10 batang per hari. Mengkonsumsi obat resep atau obat non-resep dalam waktu 7 hari sebelum hari pertama pemberian obat. Donor darah atau kehilangan darah 300 mL (atau lebih) dalam waktu 3 (tiga) bulan sebelum hari pertama pemberian obat. Memiliki riwayat penyalahgunaan maupun ketergantungan alkohol atau obat terlarang dalam waktu 12 bulan terakhir sebelum hari pertama pemberian obat. Memiliki Hipersensitivitas atau kontraindikasi yang diketahui terhadap obat yang akan diujikan. Setiap kondisi bedah atau medis (sekarang atau riwayat) yang mungkin secara signifikan mempengaruhi penyerapan, distribusi, metabolisme atau ekskresi dari uji, mis. penyakit gastrointestinal termasuk lambung atau tukak duodenum atau riwayat operasi lambung. Riwayat perdarahan atau gangguan pembekuan darah. Kelainan hematologi yang signifikan secara klinis. Kelainan urinalisis yang signifikan secara klinis. insufisiensi ginjal (konsentrasi kreatinin plasma ≥ 1,50 mg / dL). Riwayat atau adanya disfungsi hati (SGPT, alkali fosfat, bilirubin total ≥ 1,5 ULN). Hasil positif tes HBsAg, HCV, dan / atau HIV. |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | AUC0-t , Cmax |
| Metric/method of measurement | Parameter farmakokinetik yang diukur adalah (studi dosis tunggal): - AUC0-t : Luas area dibawah kurva kadar analit dalam plasma terhadap waktu dari waktu 0 sampai waktu terakhir kadar obat diukur (... jam), yang dihitung secara trapezoidal - AUC0-∞ : Luas area di bawah kurva kadar analit dalam plasma vs waktu dari waktu kurva yang terekstrapolasi sampai waktu tidak terhingga, yang dihitung dengan rumus: AUC0-∞= AUCt +Ct/ke - Cmax : kadar maksimum analit dalam plasma yang diperoleh dari data hasil pengamatan - tmax : waktu untuk mencapai kadar puncak - t½ : waktu paruh terminal |
| Timepoint(s) of measurement | 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, dan 72 jam |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | AUC0-inf , Tmax, Half life |
| Metric/method of measurement (SO1) | |
| Timepoint(s) of measurement (SO1) | |
| 9. Study Results | |
| Brief summary of study results | |
| Date of results summaries | 02-08-2023 |
| Participant flow | |
| Baseline characteristic | |
| Adverse events | |
| Outcome measures | |
| 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 | |