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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

36

Phase

  • 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

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
Intervention / Treatment
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

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

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

PT Kalbe Farma Tbk

Collaborators

PT Pharma Metric Labs

Investigators

  • 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)

December 10, 2020

Primary Completion (Actual)

January 14, 2021

Study Completion (Actual)

February 3, 2021

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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