Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule (Nufaprazol) Manufactured by PT. Nufarindo in Comparison with 30 mg Prevacid® Delayed-Release Capsule Manufactured by Takeda Italia S.P.A, Distribution By Takeda Pharmaceuticals America Inc., USA.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-CDBZ2AM
Tanggal Input Registry : 09-10-2023

26-06-2022
Cmax, AUCt
 
Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule (Nufaprazol) Manufactured by PT. Nufarindo in Comparison with 30 mg Prevacid® Delayed-Release Capsule Manufactured by Takeda Italia S.P.A, Distribution By Takeda Pharmaceuticals America Inc., USA.
Bioequivalence Study of 30 mg Lansoprazole Delayed-Release Capsule (Nufaprazol) Manufactured by PT. Nufarindo in Comparison with 30 mg Prevacid® Delayed-Release Capsule Manufactured by Takeda Italia S.P.A, Distribution By Takeda Pharmaceuticals America Inc., USA.
Interventional
30 mg Lansoprazole Delayed-Release Capsule (Nufaprazol)
30
 

Inclusion Criteria:

had read the subject information and signed informed consent documents, age range from 18 – 55 years body mass index between 18–25 kg/m2, had a normal electrocardiogram, had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg), had the heart rate within normal range (60 – 100 bpm), had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening, agreed to use protection (condom) before any intercourse with their spouse during the study

Exclusion Criteria:

those who were pregnant and/or nursing women (for women), those with history of contraindication or hypersensitivity to lansoprazole, or other proton pump inhibitor drugs or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction, those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease,those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities, those who were using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day, those who had participated in any clinical study within 3 months prior to the study (
 
KET-447/UN2.F1/ETIK/PPM.00.02/2021
Not applicable
PPUK/PPUB number
609/STD/PML/2021
Nabila Mudin S