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.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT Omega Medika Farma Laboratori
No Registry
INA-4DKQ560
Tanggal Input Registry : 21-10-2024

06-08-2024
AUCt and Cmax
AUCinf, tmax, half-life
 
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.
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.
Interventional
Test Drug: Vonoprazan Fumarate (Vonoprazan 20 mg) film coated tablet produced by PT Pratapa Nirmala
24
 

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.
 
No. KET-452/ UN2.F1/ETIK/PPM.00.02/2024
Not applicable
PPUK/PPUB number
Protocol No. 198/FORM/OMF/2023 ver 01 Report No. 156/RPT/OMF/2024 ver 00
apt. Tasha Yuliandra, M.Sc