Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Kalbe Farma

Status

Completed

Conditions

Drug Use

Treatments

Drug: Omeprazole 20 mg Capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT05849883

551/STD/PML/2020

Details and patient eligibility

About

The study was conducted to investigate whether 20 mg omeprazole capsules manufactured by PT. Dankos Farma for PT. Hexpharm Jaya is bioequivalent to its reference product, 20 mg Losec® capsules manufactured by AstraZeneca AB, Sweden, imported by PT. AstraZeneca Indonesia.

Full description

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.

Enrollment

36 patients

Sex

All

Ages

18 to 44 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.