Bioequivalence study of manufactured by Esmoprazole 40mg Cap. Kooshan Pharmed. Co. (Eosoflux) in Iranian healthy volunteers

In- Vivo Bioequivalence study of Esmoprazole 40mg Cap. Kooshan Pharmed. Co. (Eosoflux) with brand drugs (Nexium® 40mg Cap., AstraZeneca, UK) in Iranian healthy volunteers.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N7

Enrollment

Registered

2020-08-02

Start date

2020-09-19

Completion date

Unknown

Last updated

2020-08-17

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

Conditions

In this study the bioequivalence of test and brand of Glorenta® will evaluated..

Interventions

Intervention 1: Intervention group1: Single dose of 40 mg Esomeprazole capsule (Nexium 40mg Cap., Astra-Zeneca, UK)Pharmaceutical Company as a reference product. Intervention 2: Intervention group2:S

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General health(liver, heart, kidney) Body mass index(18-28) Informed consent Age(18-60)

Exclusion criteria

Exclusion criteria: Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug

Design outcomes

Primary

Measure	Time frame
Drug analysis in plasma or whole blood. Timepoint: After blood sampling. Method of measurement: HPLC,LC-MS/MS or UPLC-MS/MS.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactJavad Shokri

Tabriz University of Medical Sciences

shokri.j@gmail.com+98 41 3334 8489

Outcome results

None listed

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