BIOEQUIVALENCE STUDY OF VONOPRAZAN FILM-COATED TABLET 20 MG PRODUCED BY PTDEXA MEDICA IN COMPARISON WITH THECOMPARATOR DRUG (VOCINTI®FILM-COATED TABLET 20MG MANUFACTURED BY TAKEDA PHARMACEUTICAL COMPANY LIMITED (HIKARI PLANT) –JAPAN, PRIMARY PACKED BY KOKANDO CO., LTD. –JAPAN, IMPORTED AND SECONDARY PACKED BY PT TAKEDA INDONESIA –INDONESIA) WHEN ADMINISTERED UNDER FASTINGCONDITION INHEALTHYADULTSUBJECTS
| 1. Background | |
|---|---|
| Registration Number | INA-9GY3W2TP |
| Date of registry approval | 14-07-2025 |
| Registration Date | 09-07-2025 |
| Secondary identifiers | No |
| Name of issuing authority (for example protocol number, other registries, etc) | |
| Secondary identifier number | |
| Scientific study title | BIOEQUIVALENCE STUDY OF VONOPRAZAN FILM-COATED TABLET 20 MG PRODUCED BY PTDEXA MEDICA IN COMPARISON WITH THECOMPARATOR DRUG (VOCINTI®FILM-COATED TABLET 20MG MANUFACTURED BY TAKEDA PHARMACEUTICAL COMPANY LIMITED (HIKARI PLANT) –JAPAN, PRIMARY PACKED BY KOKANDO CO., LTD. –JAPAN, IMPORTED AND SECONDARY PACKED BY PT TAKEDA INDONESIA –INDONESIA) WHEN ADMINISTERED UNDER FASTINGCONDITION INHEALTHYADULTSUBJECTS |
| Public (popular study title) | BIOEQUIVALENCE STUDY OF VONOPRAZAN FILM-COATED TABLET 20 MG PRODUCED BY PTDEXA MEDICA IN COMPARISON WITH THECOMPARATOR DRUG (VOCINTI®FILM-COATED TABLET 20MG MANUFACTURED BY TAKEDA PHARMACEUTICAL COMPANY LIMITED (HIKARI PLANT) –JAPAN, PRIMARY PACKED BY KOKANDO CO., LTD. –JAPAN, IMPORTED AND SECONDARY PACKED BY PT TAKEDA INDONESIA –INDONESIA) WHEN ADMINISTERED UNDER FASTINGCONDITION INHEALTHYADULTSUBJECTS |
| 2. Sponsor and Funding | |
| Primary Sponsor | PT Dexa Medica |
| Source(s) of monetary or material support | PT Dexa Medica |
| Other partners | Not Specified |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Danang Agung Yunaidi, MD |
| City | KOTA TANGERANG SELATAN |
| Country | Indonesia |
| Principal investigator's affiliation | PT Equilab International |
| Principal Investigator's email address | danang@equilab-int.com |
| Public Queries | |
| Contact person name for public queries | Kartika Widyanty |
| Address for public queries | Titan Center, PT Dexa Medica, Bintaro Sektor 7 |
| City | KOTA TANGERANG SELATAN |
| Country | Indonesia |
| ZIP | 15224 |
| Affiliation for public queries | Kartika Widyanty |
| Email address for public queries | tika.wdy@gmail.com |
| Phone number for public queries | 089618045673 |
| Scientific Queries | |
| Name of Contact for scientific queries | Kartika Widyanty |
| Address for scientific queries | Titan Center, PT Dexa Medica, Bintaro Sektor 7 |
| City | KOTA TANGERANG SELATAN |
| Country | Indonesia |
| ZIP | 15224 |
| Affiliation of scientific queries contact | PT Dexa Medica |
| Email address for scientific queries | tika.wdy@gmail.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | No. S-154/UN2.F1/ETIK/PPM.00.02/2025, dated 07 March 2025 |
| Name of Ethics committee | Ethics Committee of the Medical Faculty, Universitas Indonesia |
| Date of Ethic approval | 07-03-2025 |
| Contact details of Ethic Committee (phone, email, and office) | Gedung Fakultas Kedokteran UI Jalan Salemba Raya No.6, Jakarta Phone : 0213912477 Email : humas@fk.ui.ac.id |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | RG.01.02.321.03.25.03441/UB |
| 5. Status | |
| Countries of recruitment | Indonesia |
| Study sites in Indonesia | PT Equilab International |
| Recruitment status | Complete |
| Date of first enrollment | 09-04-2025 |
| Targeted Sample size | 00028 - |
| Number of enrolled participants | 28 |
| Date of study completion (last participant, last visit) | 18-04-2025 |
| 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 | Other |
| 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) | 20 mg of vonoprazan produced by PT Dexa Medica |
| Control intervention (control arm) | 20 mg of vonoprazan manufactured by Takeda Pharmaceutical Company Limited (Hikari Plant) –Japan, primary packed by Kokando Co., Ltd. –Japan, imported and secondary packed by PTTakeda Indonesia –Indonesia (Vocinti®Film-Coated Tablet 20mg) |
| Intervention assignment | Crossover |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Male |
| Minimum age | 18 |
| Maximum age | 55 |
| Inclusion criteria | 1. Able to participate, communicate well with the investigators and willing to provide written
informed consent to participate in the study. 2. Healthy male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during the screening and could be considered healthy based on the evaluation. 3. Aged 18 - 55 years inclusive. 4. Non-smokers. 5. Body mass index within 18 to 25 kg/m2. 6. Vital signs (after 10 minutes rest) must be within the following ranges. - Systolic blood pressure : 100 - 129 mmHg - Diastolic blood pressure : 60 - 84 mmHg - Pulse rate : 60 - 90 bpm 7. Willing to practice abstention or use non-hormonal contraception during the study. |
| Exclusion criteria | 1. History of allergy or hypersensitivity or contraindication to alprazolam or other benzodiazepine or allied drug.
2. Pregnant or lactating female (urinary pregnancy test will be applied to female subjects at screening and before taking the study drug). 3. Any major illness in the past 90 days or clinically significant ongoing chronic medical illness. 4. Presence of any clinically significant abnormal values during screening e.g. significant abnormality of liver function test (AST, ALT, alkaline phosphatase, total bilirubin, direct bilirubin ≥ 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL and ureum ≥ 1.5 ULN), etc. 5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV. 6. Clinically significant hematology abnormalities. 7. Clinically significant electrocardiogram (ECG) abnormalities. 8. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery. 9. Past history of anaphylaxis or angioedema. 10. History of drug or alcohol abuse within 12 months prior to screening for this study. 11. Participation in any clinical trial within the past 90 days calculated from the last visit until this study’s first dosing day. 12. History of any bleeding or coagulative disorders. 13. Presence of difficulty in accessibility of veins in left or right arm during screening. 14. A donation or significant blood loss within 90 days before this study’s first dosing day. 15. Intake of any prescription, non-prescription drug (including hormonal contraception), food supplements or herbal medicines within 21 days of this study’s first dosing day. 16. Difficulty in swallowing capsule or tablet |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | Cmax, AUC0-t, AUC0-inf, tmax, and t½ |
| Metric/method of measurement | ANOVA including sequence, subjects within sequence, period, and formulationwere performed on the ln-transformed data for AUC0-tand Cmax.The difference in tmaxwas analyzed non-parametrically on the original data using Wilcoxon matched-pairs signed-rank test. The t½difference was analyzed using Student’s paired t-test |
| Timepoint(s) of measurement | The subjects blood samples will be taken at a certain time. Drug administration, drink and meal for subjects, and subject activities will be standardized during study period. |
| 9. Study Results | |
| Brief summary of study results | Vonoprazan film-coated tablet 20 mg produced by PT Dexa Medicawas bioequivalent to the comparator drug (Vocinti®Film-Coated Tablet 20mg manufactured by Takeda Pharmaceutical Company Limited (Hikari Plant) –Japan, primary packed by Kokando Co., Ltd. –Japan, imported and secondary packed by PT Takeda Indonesia –Indonesia) |
| Date of results summaries | 02-07-2025 |
| Participant flow | Not Specified |
| Baseline characteristic | |
| Adverse events | Not Specified |
| Outcome measures | Not Specified |
| 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 | Not Specified |