Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2021-02-03

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.

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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.

Conditions

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Drug Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Omeprazole 20 mg capsules

Subjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water

Group Type EXPERIMENTAL

Omeprazole 20 mg Capsules

Intervention Type DRUG

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

Losec® 20 mg capsules

Subjects were given a single dose of 20 mg omeprazole of either formulation (test or reference) with 240 ml of water

Group Type ACTIVE_COMPARATOR

Omeprazole 20 mg Capsules

Intervention Type DRUG

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

Interventions

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Omeprazole 20 mg Capsules

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

Intervention Type DRUG

Other Intervention Names

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Losec® 20 mg capsules

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes