Bioequivalance study of Omeprazole 20mg

Bioequivalance study of Omeprazole 20mg capsules manufactured by Sina Pishgam Darou Novin pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Omprazole capsules manufactured by Hexal

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200513047423N2

Enrollment

Registered

2021-10-07

Start date

2021-10-08

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalance Omeprazole 20mg.

Interventions

Intervention 1: Intervention group: OneOmeprazple capsule 20mg manufactured by Sina Pishgam Darou Novin (Test drug) is administrated to each of 12 healthy volunteers of group 1. Intervention 2: Interv

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy liver Healthy kidney Observing BMI

Exclusion criteria

Exclusion criteria: Out of age ranges No smoker Unhealthy liver and kidney Pregnancy

Design outcomes

Primary

Measure	Time frame
Increasing plasma concentration after administration of Omeprazple capsules till Tmax and then decreasing plasma concentration after Tmax. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each healthy volunteers. Hence the Tmax of Omeprazole is between 1.5 and 2 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase. Method of measurement: In this study, the variable is plasma concentration of Omeprazole. High performance liquid chromatography is used to determine the concentration of Omeprazole in plasma.	—

Measure

Time frame

Increasing plasma concentration after administration of Omeprazple capsules till Tmax and then decreasing plasma concentration after Tmax. Timepoint: Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each healthy volunteers. Hence the Tmax of Omeprazole is between 1.5 and 2 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase. Method of measurement: In this study, the variable is plasma concentration of Omeprazole. High performance liquid chromatography is used to determine the concentration of Omeprazole in plasma.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir mehdizadeh

Ofogh pharmed laboratory

a_mehdizadeh@gmail.com+98 21 6673 8727

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026