Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsule Manufactured by PT. Bernofarm in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Sweden, Imported by AstraZeneca, Indonesia

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Pharma Metric Labs
No Registry
INA-EMAMLXK
Tanggal Input Registry : 03-04-2023

12-04-2021
90% Confidence Interval, Cmax and AUCt
N.A
 
Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsule Manufactured by PT. Bernofarm in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Sweden, Imported by AstraZeneca, Indonesia
Bioequivalence Study of 20 mg Omeprazole Delayed Release Capsule Manufactured by PT. Bernofarm in Comparison with 20 mg Losec® Capsule Manufactured by AstraZeneca AB, Sweden, Imported by AstraZeneca, Indonesia
Interventional
Subjects were given a single dose of 1 tablet of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water. Subjects were administered the drug products in a sitting posture. Subjects were asked to maintain upright position (standing or sitting) for 1 hour after dosing.
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Inclusion Criteria:

The inclusion criteria were healthy male or female subjects who/with: 1. had read the subject information and signed informed consent documents 2. age range from 18 – 55 years 3. body mass index between 18 – 25 kg/m2 4. had a normal electrocardiogram 5. had the blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg) 6. had the heart rate within normal range (60 – 100 bpm) 7. had absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. 8. acceptance to use protection (condom) if there is any intercourse with their spouse during study

Exclusion Criteria:

This study was not eligible for: 1. those who were pregnant and/or nursing condition (for women). 2. those with history of contraindication or hypersensitivity to omeprazole, 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. 3. 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. 4. those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities. 5. 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. 6. those who had participated in any clinical study within 3 months prior to the study (
 
KET-204/UN2.F1/ETIK/PPM.00.02/2021
591/STD/PML/2020
Nabila Mudin S