CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Omeprazole 20 mg Capsulesdrug
Likely dose
Omeprazole 20 mg Capsulesfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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NCT05849883N/ACompleted
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Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

PT Kalbe Farma Tbk·interventional·Posted May 9, 2023·Updated May 9, 2023

In Brief

A clinical study evaluating Omeprazole 20 mg Capsules for Drug Use. Completed, enrolled 36 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Use
CountriesIndonesia
CollaboratorsPT Pharma Metric Labs

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 9, 2023
Enrollment StartDec 10, 2020
Primary CompletionJan 14, 2021
Study CompletionFeb 3, 2021
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 3.1 years ago

Interventions

Omeprazole 20 mg Capsulesdrug

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