Bio equivalence study of Esomeprazole 40 mg

Bioequivalance study of esomeprazol 40 mg capsules manufactured by sina pishgam daru novin pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Nexium 40 capsules manufactured by AstraZeneca

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200513047423N3

Enrollment

Registered

2021-11-09

Start date

2021-12-31

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

Bio equivalence Esomeprazole 40 mg.

Interventions

Intervention 1: Intervention group 1: One esomeprazole 40 mg capsule manufactured by sina pishgam daru novin company( Test drug) is administrated to each of 12 healthy volunteers of group 1. Intervent

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 smoking Unhealthy liver and kidney Pregnancy

Design outcomes

Primary

Measure	Time frame
Increasing plasma concentration after administration of esomeprazole 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 esomeprazole is between 1.5 and 2.5 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase.In the elimination phase (after Tmax)blood sampling carry out each hours. Method of measurement: In this study, the variable is plasma concentration of esomeprazole. High performance liquid chromatography is used to determine the concentration of esomeprazole in plasma.	—

Measure

Time frame

Increasing plasma concentration after administration of esomeprazole 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 esomeprazole is between 1.5 and 2.5 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase.In the elimination phase (after Tmax)blood sampling carry out each hours. Method of measurement: In this study, the variable is plasma concentration of esomeprazole. High performance liquid chromatography is used to determine the concentration of esomeprazole in plasma.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Amir mehdizadeh

Ofogh pharmed labratory

A_mehdizadeh@yahoo.com+98 21 6673 9211

Outcome results

None listed

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