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Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Drug Use Clinical Trial

Official title:
Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05849883
Study type Interventional
Source PT Kalbe Farma Tbk
Contact
Status Completed
Phase N/A
Start date December 10, 2020
Completion date February 3, 2021
View Details
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