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Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

NCT05849883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-05-09

No results posted yet for this study

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.

Conditions

  • Drug Use

Interventions

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

Sponsors & Collaborators

  • PT Pharma Metric Labs

    collaborator INDUSTRY

  • PT Kalbe Farma Tbk

    lead INDUSTRY

Principal Investigators

  • Frans D Suyatna · PT Pharma Metric Labs

  • I Gusti Putu Bagus Diana Virgo · PT Pharma Metric Labs

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2021-01-14
Completion
2021-02-03

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849883 on ClinicalTrials.gov