Uji Perbandingan Kualitas Obat Selvim® 10 (Simvastatin 10 mg) dengan Obat Standar Zocor® 10 ( Simvastatin 10 mg)
| 1. Background | |
|---|---|
| Registration Number | INA-GOMZ75T |
| Date of registry approval | 29-10-2024 |
| Registration Date | 10-10-2024 |
| Secondary identifiers | No |
| Name of issuing authority (for example protocol number, other registries, etc) | |
| Secondary identifier number | |
| Scientific study title | Bioequivalence Study of Selvim® 10 mg (Simvastatin 10 mg) Caplet Produced by PT IFARS Pharmaceutical Laboratories Compared with Zocor® 10 mg (Simvastatin 10 mg) Tablet Produced by Organon Pharma (UK) Limited |
| Public (popular study title) | Uji Perbandingan Kualitas Obat Selvim® 10 (Simvastatin 10 mg) dengan Obat Standar Zocor® 10 ( Simvastatin 10 mg) |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT IFARS Pharmaceutical Laboratories |
| Source(s) of monetary or material support | Sponsor : PT IFARS Pharmaceutical Laboratories |
| Other partners | Advanced Pharmaceutical Sciences Laboratories, Faculty of Pharmacy Universitas Gadjah Mada |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Prof. Dr. apt. Zullies Ikawati |
| City | Sleman |
| Country | Indonesia |
| Principal investigator's affiliation | Advanced Pharmaceutical Sciences Laboratories, Faculty of Pharmacy Universitas Gadjah Mada |
| Principal Investigator's email address | zullies_ikawati@ugm.ac.id |
| Public Queries | |
| Contact person name for public queries | Hanifah Ratna Yuliani, S.Si. |
| Address for public queries | Sekip Utara, Sinduadi, Mlati, Sleman, Special Region of Yogyakarta |
| City | Sleman |
| Country | Indonesia |
| ZIP | 55281 |
| Affiliation for public queries | Advanced Pharmaceutical Sciences Laboratories, Faculty of Pharmacy Universitas Gadjah Mada |
| Email address for public queries | lab-aps.farmasi@ugm.ac.id |
| Phone number for public queries | +62822-2003-7512 |
| Scientific Queries | |
| Name of Contact for scientific queries | apt. Arief Rahman Hakim, M.Si. |
| Address for scientific queries | Sekip Utara, Sinduadi, Mlati, Sleman, Special Region of Yogyakarta |
| City | Sleman |
| Country | Indonesia |
| ZIP | 55281 |
| Affiliation of scientific queries contact | Advanced Pharmaceutical Sciences Laboratories, Faculty of Pharmacy Universitas Gadjah Mada |
| Email address for scientific queries | hakim_ar@ugm.ac.id |
| 4. IRB & Regulatory | |
| Ethical Approval number | KE/FK/1883/EC/2023 |
| Name of Ethics committee | Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada - Dr. Sardjito General Hospital |
| Date of Ethic approval | 01-12-2023 |
| Contact details of Ethic Committee (phone, email, and office) | Radiopoetro Building 2nd floor, West Side, Farmako Street, Sekip Utara, Yogyakarta 55128 Phone: 0274 588688, +62811-2666-869 e-mail: mhrec_fmugm@ugm.ac.id |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.02.321.02.24.02455/UB |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | Rumah Sakit Akademik Universitas Gadjah Mada and Advanced Pharmaceutical Sciences Laboratories |
| Recruitment status | Complete |
| Date of first enrollment | 12-02-2024 |
| Targeted Sample size | 00034 - |
| Number of enrolled participants | 34 |
| Date of study completion (last participant, last visit) | 15-07-2024 |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | Healthy subjects |
| Purpose of the study | The study is conducted to obtain scientific evidence regarding the quality of the drug in vivo by measuring the rate and amount of drugs absorbed into the systemic circulation, where Selvim 10 (Simvastatin 10 mg) manufactured by PT IFARS Pharmaceutical La |
| 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) | |
| Control intervention (control arm) | |
| Intervention assignment | |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male, Female |
| Minimum age | 18 |
| Maximum age | 44 |
| Inclusion criteria | - Healthy subjects, with healthy criteria based on clinical laboratory tests which include liver function, renal function, routine blood test, urine analysis, medical history, and physical examination.
- The blood pressure and heart rate are acceptable (systolic blood pressure of 100-120 mmHg, diastolic blood pressure of 60-80 mmHg, and heart rate of 60-90 bpm). - The result of the ECG examination is acceptable. - The result of HCV serology must be negative. - The result of serological tests for Hepatitis B (HBsAg) and HIV (anti-HIV) must be negative. - The result of rapid antigen COVID-19 test must be negative. - Men and women. - Age is between 18 - 44 years. - Weight is within a normal range that follows the formula: BMI = Weight (kg) / Height2 (m) = 18 - 25 - Currently not using any medication in a week before the study. - Willing to participate in the study by signing an informed consent form. |
| Exclusion criteria | - Pregnant and breastfeeding women
- Having a contraindication or an allergy to simvastatin - Having the habit of smoking and drinking alcohol - Using the contraceptive pills - Having a history of drug and alcohol dependence - Having a medical history that may affect the pharmacokinetics of the tested drug, such as gastrointestinal chronic diseases, diarrhea, gastric surgery, kidney failure, liver dysfunction, and cardiovascular disease. - Participating in another clinical trial within 3 months before the study. - Donating or losing 300 mL (or more) of blood within 3 months before the study. |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | The Cmax value of Selvim® 10 (Simvastatin 10 mg) was 10.63 ± 1.68 ng/mL and the Cmax value of Zocor® 10 (Simvastatin 10 mg) was 11.40 ± 1.63 ng/mL. The ratio of (Cmax)T/(Cmax)R value of both products was 93.06%. |
| Metric/method of measurement | The Cmax values were measured by measuring the Simvastatin concentration in blood plasma with LC-MS/MS |
| Timepoint(s) of measurement | At 0; 0.25; 0.5; 0.75; 1; 1.5; 2; 2.5; 3; 3.5; 4; 4.5; 5; 6; 8; 10; 12; and 24 hours |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | The area under curve (AUC0-t) of Selvim® 10 (Simvastatin 10 mg) was 46.32 ± 7.45 ng.hour/mL and the AUC0-t of Zocor® 10 (Simvastatin 10 mg) was 46.46 ± 7.97 ng.hour/mL. The ratio of (AUC0-t)T/(AUC0-t)R was 100.82%. |
| Metric/method of measurement (SO1) | The AUC0-t values were calculated based on the geometric mean of the area under simvastatin concentration vs time curve |
| Timepoint(s) of measurement (SO1) | At 0; 0.25; 0.5; 0.75; 1; 1.5; 2; 2.5; 3; 3.5; 4; 4.5; 5; 6; 8; 10; 12; and 24 hours |
| 9. Study Results | |
| Brief summary of study results | The geometric mean ratio (Cmax)T/(Cmax)R of Selvim® 10 (Simvastatin 10 mg) and Zocor® 10 (Simvastatin 10 mg) is 93.06% with the 90% CI is 82.19 - 105.37% and the intra-subject CV 29.28%. The geometric mean ratio (AUC0-t)T/(AUC0-t)R of Selvim® 10 (Simvastatin 10 mg) and Zocor® 10 (Simvastatin 10 mg) is 100.82% with the 90% CI is 87.36 - 116.35% and the intra-subject CV is 33.77%. The geometric mean ratio (AUC0-inf)T/(AUC0-inf)R is 103.19% with the 90% CI is 89.56 - 118.88% and the intra-subject CV is 33.37%. Based on the bioequivalence criteria of Indonesian Food and Drug Regulatory (BPOM), the geometric mean ratio (Cmax)T/(Cmax)R = 1.00 with 90% CI = 80.00-125.00% and the geometric mean ratio (AUC)T/(AUC)R = 1.00 with 90% CI = 80.00-125.00%, Selvim® 10 (Simvastatin 10 mg) and Zocor® 10 (Simvastatin 10 mg) is concluded as bioequivalent. |
| Date of results summaries | 12-01-2024 |
| 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 | not specified |