Bioequivalence Study of 40 mg Esomeprazole Gastro-Resistant Coated Tablets Manufactured by PT. Dankos Farma in Comparison with 40 mg Nexium® MUPS Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden.

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-WF88388
Tanggal Input Registry : 02-09-2024

29-01-2023
Cmax, AUCt
 
Bioequivalence Study of 40 mg Esomeprazole Gastro-Resistant Coated Tablets Manufactured by PT. Dankos Farma in Comparison with 40 mg Nexium® MUPS Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden.
Bioequivalence Study of 40 mg Esomeprazole Gastro-Resistant Coated Tablets Manufactured by PT. Dankos Farma in Comparison with 40 mg Nexium® MUPS Film-Coated Tablets Manufactured by AstraZeneca AB, Sweden.
Interventional
Esomeprazole 40 mg gastro-resistant coated tablet
32
 

Inclusion Criteria:

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

Exclusion Criteria:

those who were pregnant and/or nursing women (for women), those with history of contraindication or hypersensitivity to esomeprazole, or other proton pump inhibitors or other ingredients in the study products, 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-964/UN2.F1/ETIK/PPM.00.02/2020
Not applicable
PPUK/PPUB number
545/STD/PML/2020
Nabila Mudin S