Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

May 8, 2023 updated by: PT Kalbe Farma Tbk
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10520
        • PT Pharma Metric Labs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: 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
Other Names:
  • Losec® 20 mg capsules
Active Comparator: 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
Drug: 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
Other Names:
  • Losec® 20 mg capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Ratio of Cmax
Time Frame: 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
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
Time Frame: 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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics Parameter of Cmax
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PT Kalbe Farma Tbk

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PT Pharma Metric Labs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frans D Suyatna, PT Pharma Metric Labs
  • Study Director: I Gusti Putu Bagus Diana Virgo, PT Pharma Metric Labs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 551/STD/PML/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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