Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Conditions
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Drug Use

Intervention / Treatment
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* Drug: Omeprazole 20 mg Capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, single blind, single dose, 2-treatment, 3-sequence, 3-period partial replicate design study with one week washout period in 36 healthy subjects under fasting condition.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omeprazole 20 mg capsules<br>Subjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water | Drug: Omeprazole 20 mg Capsules<br>* Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production<br>* Other names: Losec® 20 mg capsules;|
| Active Comparator: Losec® 20 mg capsules<br>Subjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water | Drug: Omeprazole 20 mg Capsules<br>* Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production<br>* Other names: Losec® 20 mg capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Ratio of Cmax | The ratio between maximum concentration of test drug and reference drug after drug administration | before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration | 
| Geometric Mean Ratio of AUCt | The ratio between area under curve from 0 to 10 hours of test drug and reference drug | before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics Parameter of Cmax | Maximum plasma concentration (Cmax) | before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration | 
| Pharmacokinetics Parameter of AUCt | Area Under Curve from 0 to 10 hours (AUCt) | before dosing and at 15, 30, 45, 60, 75, 90, 105 minutes, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, and 10 hours after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omeprazole, Bioequivalence Study