Bioequivalence study of Vonoprazan Fumarate (Vonoprazan 20 mg) film coated tablet produced by PT Pratapa Nirmala in comparison with Vocinti® (Vonoprazan fumarate ~ Vonoprazan 20 mg) film coated tablet manufactured by Takeda Pharmaceutical Company Ltd., Hikari, Japan, primary packed by Kokando Co., Ltd., Toyama, Japan, imported and secondary packed by PT Takeda Indonesia.
| 1. Background | |
|---|---|
| Registration Number | INA-4DKQ560 |
| Date of registry approval | 29-10-2024 |
| Registration Date | 21-10-2024 |
| Secondary identifiers | Yes |
| Name of issuing authority (for example protocol number, other registries, etc) | Badan Pengawas Obat dan Makanan, Bioequivalence Study Protocol Approval No. RG.01.02.321.05.24.02646/UB |
| Secondary identifier number | Protocol No. 198/FORM/OMF/2023 ver 01 Report No. 156/RPT/OMF/2024 ver 00 |
| Scientific study title | Bioequivalence study of Vonoprazan Fumarate (Vonoprazan 20 mg) film coated tablet produced by PT Pratapa Nirmala in comparison with Vocinti® (Vonoprazan fumarate ~ Vonoprazan 20 mg) film coated tablet manufactured by Takeda Pharmaceutical Company Ltd., Hikari, Japan, primary packed by Kokando Co., Ltd., Toyama, Japan, imported and secondary packed by PT Takeda Indonesia. |
| Public (popular study title) | Bioequivalence study of Vonoprazan Fumarate (Vonoprazan 20 mg) film coated tablet produced by PT Pratapa Nirmala in comparison with Vocinti® (Vonoprazan fumarate ~ Vonoprazan 20 mg) film coated tablet manufactured by Takeda Pharmaceutical Company Ltd., Hikari, Japan, primary packed by Kokando Co., Ltd., Toyama, Japan, imported and secondary packed by PT Takeda Indonesia. |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT Pratapa Nirmala |
| Source(s) of monetary or material support | PT Pratapa Nirmala |
| Other partners | PT Omega Medika Farma Laboratori |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Prof. dr. Franciscus D. Suyatna, Ph.D., Sp.FK |
| City | Jakarta |
| Country | Indonesia |
| Principal investigator's affiliation | PT Omega Medika Farma Laboratori |
| Principal Investigator's email address | admin@omegaresearch.id |
| Public Queries | |
| Contact person name for public queries | apt. Tasha Yuliandra, M.Sc |
| Address for public queries | Jalan Kramat Raya No. 61A, 10450 |
| City | Jakarta |
| Country | Indonesia |
| ZIP | 10450 |
| Affiliation for public queries | PT Omega Medika Farma Laboratori |
| Email address for public queries | admin@omegaresearch.id |
| Phone number for public queries | 021- 3905831 |
| Scientific Queries | |
| Name of Contact for scientific queries | apt. Tasha Yuliandra, M.Sc |
| Address for scientific queries | Jalan Kramat Raya No. 61A, 10450 |
| City | Jakarta |
| Country | Indonesia |
| ZIP | 10450 |
| Affiliation of scientific queries contact | PT Omega Medika Farma Laboratori |
| Email address for scientific queries | admin@omegaresearch.id |
| 4. IRB & Regulatory | |
| Ethical Approval number | No. KET-452/ UN2.F1/ETIK/PPM.00.02/2024 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan FK Universitas Indonesia – RSUPN Dr. Cipto Mangunkusumo |
| Date of Ethic approval | 25-03-2024 |
| Contact details of Ethic Committee (phone, email, and office) | Gedung H Fakultas Kedokteran UI, Jalan Salemba Raya No. 6 Jakarta 10430, Po. Box 1358, Telp: 021 – 3157008 Website: komite-etik.fk.ui.ac.id |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | No. RG.01.02.321.05.24.02646/UB |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | Jakarta |
| Recruitment status | Complete |
| Date of first enrollment | 06-08-2024 |
| Targeted Sample size | 00024 - |
| Number of enrolled participants | 24 |
| Date of study completion (last participant, last visit) | 05-09-2024 |
| 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) | Test Drug: Vonoprazan Fumarate (Vonoprazan 20 mg) film coated tablet produced by PT Pratapa Nirmala |
| Control intervention (control arm) | Reference Drug: Vocinti® (Vonoprazan fumarate ~ Vonoprazan 20 mg) film coated tablet manufactured by Takeda Pharmaceutical Company Ltd., Hikari, Japan, |
| Intervention assignment | Crossover |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Not specified |
| Minimum age | 18 |
| Maximum age | 55 |
| Inclusion criteria | Willing to sign the informed consent; Age 18 – 55 years; Body mass index between 18 – 25 kg/m2; Normotensive (systolic blood pressure 100 – 120 mmHg, diastolic blood pressure 60-80 mmHg), heart rate 60 – 90 beats per minute; Healthy male/female, (healthy criteria is determined by normal values or if outside the normal range of values but no clinically significant effects based on doctors' justification on the result of laboratory test include routine hematology, liver function, renal function, blood glucose, and urinalysis; history of disease, and physical examination) |
| Exclusion criteria | Contraindicated and/or has history of hypersensitivity to Vonoprazan or related drug; With history or present medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction, or cardiovascular disease; Show abnormal result or not within the acceptance range (clinically significant effect based on doctor’s justification) in the electrocardiography (ECG) test results, Using any medication (prescription or non-prescription drug, food supplement, herbal medicine) within 7 days prior to the study; Participated in any clinical study within 3 months prior to the dosing day; Donated or lost 300 mL (or more) of blood within 3 months prior to the dosing day; Smoke more than 9 sticks of cigarettes a day; Have any bleeding or coagulation disorder; Indicate the positive result on test for HbsAg, Anti-HCV, and anti-HIV; Pregnant or lactating female (urinary pregnancy test applied to female subjects at screening and before taking the study dug), With the history of alcohol and drug abuse; To reduce the risk of Covid-19 transmission, the exclusions criteria below must be applied: a. With history of direct contact with a Covid-19 positive person within last 14 days; With history or present sore throat, fever (temperature more than 37°C) or short of breath within last 14 days; Positive to Covid-19 antigen rapid test, for those who do not yet receive a complete primary vaccination against Covid-19 and at least the first booster. |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | AUCt and Cmax |
| Metric/method of measurement | Vonoprazan concentration in plasma with LC/MS |
| Timepoint(s) of measurement | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours after dosing |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | AUCinf, tmax, half-life |
| Metric/method of measurement (SO1) | Vonoprazan concentration in plasma with LC/MS |
| Timepoint(s) of measurement (SO1) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours after dosing |
| 9. Study Results | |
| Brief summary of study results | From the result of study, it was concluded that Vonoprazan Fumarate ~ Vonoprazan 20 mg film coated tablet batch number 1HK165 produced by PT Pratapa Nirmala was bioequivalent to its reference Vocinti® (Vonoprazan Fumarate ~ Vonoprazan 20 mg) film coated tablet batch number 12534417 manufactured by Takeda Pharmaceutical Company Ltd., Hikari, Japan, primary packed by Kokando Co., Ltd., Toyama, Japan, imported and secondary packed by PT Takeda Indonesia. |
| Date of results summaries | 18-10-2024 |
| Participant flow | Enrolled: 24 subjects
Completed: 23 subjects |
| 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)) | |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | |