Bioequivalence Study of 20 mg Omeprazole Capsules in Indonesia Healthy Subject

Not Applicable

Completed

• Conditions: Drug Use
• Interventions: Drug: Omeprazole 20 mg Capsules

• Registration Number: NCT05849883
• Lead Sponsor: PT Kalbe Farma Tbk

Brief 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.

Study Timeline

• Study Start: 2020-12-10
• Primary Completion: 2021-01-14
• Study Completion: 2021-02-03
• Study First Submitted: 2023-02-08
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-08
• Last Update Submitted: 2023-05-08
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Omeprazole 20 mg capsules	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
Losec® 20 mg capsules	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

Primary Outcome Measures

Name	Time	Method
Geometric Mean Ratio of 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	The ratio between area under curve from 0 to 10 hours of test drug and reference drug
Geometric Mean Ratio of 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	The ratio between maximum concentration of test drug and reference drug after drug administration

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics Parameter of 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	Maximum plasma concentration (Cmax)
Pharmacokinetics Parameter of 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	Area Under Curve from 0 to 10 hours (AUCt)

Trial Locations

Locations (1)

PT Pharma Metric Labs; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia