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

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Not Specified
No Registry
INA-0OL422PX
Tanggal Input Registry : 09-07-2025

09-04-2025
Cmax, AUC0-t, AUC0-inf, tmax, and t½
 
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
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
Interventional
20 mg of vonoprazan produced by PT Dexa Medica
28
 

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
 
No. S-154/UN2.F1/ETIK/PPM.00.02/2025, dated 07 March 2025
Not applicable
PPUK/PPUB number
Kartika Widyanty