Bioequivalence study of Eplerenone 50mg tablet of Alborzdarou Pharm Co., IRA

Not Applicable

Conditions: I11.0
Hypertension.
Hypertensive heart disease with (congestive) heart failure

Registration Number: IRCT20190706044111N11

Lead Sponsor: Alborzdarou Pharm. Co.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 24

Inclusion Criteria

Aged between 18 - 50 years
- Body weight between 50 – 100 kg
- Having good health on the basis of medical history and physical & clinical examination
- Understand the procedures and give written informed consent

Exclusion Criteria

Subject showed clinically relevant deviations from normal in physical examination.
Subject had undergone surgery of the gastro-intestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment.
Subject had a history of drug or alcohol abuse.
Subject who smokes more than 10 cigarettes per day.
Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.
Subject had a history of allergic to drug

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of eplerenone. Timepoint: At 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 & 24.0 hr. after drug administration. Method of measurement: High Performance Liquid Chromatography (HPLC).

Secondary Outcome Measures