Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Thirty six healthy subjects were given a single dose of 20 mg omeprazole capsules or 20 mg Losec® capsules with 240 mL of water. Then the blood samples for omeprazole were drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation.

The inclusion criteria were healthy male or female subjects who/with:

• 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.
• accepted to use protection (condom) before any intercourse with their spouse throughout the study

Excluded from the study were:

• those who were pregnant and/or nursing women (for women).
• those with history of contraindication or hypersensitivity to omeprazole, 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 (<90 days).
• those who had donated or lost 300 ml (or more) of blood within 3 months prior to the study.
• those who smoked more than 10 cigarettes a day
• those who were reactive to SARS CoV-2 test.
• those with a history of travelling to another city within the last 14 days
• those with a history of direct contact with a COVID-19 positive person in the subject's neighborhood
• those with a history or present of sore throat, fever (with temperature more than 37°C) or dyspnea with in the last 14 days
• those who were positive to HIV, HBsAg, and HCV tests (to be kept confidential).
• those with a history of drug or alcohol abuse within 12 months prior to screening for this study.
• those who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.