Investigating the in vivo bioequivalence of Eplerenone 25 mg

In vivo fasted state bioequivalence study of Eplerenone 25 mg tablet manufactured by Kimia Ara Heram Co. compared with innovator product

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210519051345N20

Enrollment

Registered

2022-12-21

Start date

2023-01-20

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

In the present study, the products will be administered to healthy volunteers..

Interventions

Intervention 1: Intervention group: Intervention group: Intervention group will receive a single oral dose of test product (Eplerenone 25 mg tablet of Kimia Ara Heram Co.) in fasted state. Blood sampl

Eligibility

Sex/Gender

Male

Age

18 Years to 59 Years

Inclusion criteria

Inclusion criteria: General Health (in terms of Liver, Heart and Kidney)

Exclusion criteria

Exclusion criteria: Smoking History of cardiovascular disease, liver and kidney disease Pregnancy Alcohol and drug addiction History of drug allergy

Design outcomes

Primary

Measure	Time frame
Plasma concentration of drug. Timepoint: 0.5-24 hours in predetermined time intervals after drug administration. Method of measurement: HPLC (High performance liquid chromatography).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Zakeri-Milani

Tabriz University of Medical Sciences

pzakeri@tbzmed.ac.ir+98 41 3334 8801

Outcome results

None listed

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