NCT05849883

Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: PT Kalbe Farma Tbk · Industry
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Drug Use

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-12-10
• Primary completion: 2021-01-14
• Completion: 2021-02-03
• First posted: 2023-05-09
• Last updated: 2023-05-09

Locations

1 site across 1 country: Indonesia