Eplerenone tablet 50mg Abourayhan (Alderon 50mg),In-Vivo Bioequivalence in iranian healthy volunteer

In- Vivo Bioequivalence study of Eplerenone tablet 50mg Anourayhan (Alderon 50mg) with brand drugs (Inspra 50mg, Pfizer, Gremany) in Iranian healthy volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200105046010N2

Enrollment

Registered

2020-06-09

Start date

2020-05-25

Completion date

Unknown

Last updated

2020-06-15

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 Esmoprazole will evaluated..

Interventions

Intervention 1: Single dose of Eplerenone 50 mg tablet by (INSPRA® 50mg. Pfizer, Germany)Pharmaceutical Company as a reference product. Intervention 2: Single dose of 50 mg Eplerenone tablet by Abu Re

Eligibility

Sex/Gender

All

Age

18 Years to 60 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