Randomized, single-dose, crossover comparative bioequivalence study of Eplerenone 50 mg tablet of ACTOVERCO and Pfizer Inc. in 24 healthy male under fasting conditions
This study was performed to compare the pharmacokinetics and invivo parameters of Eplerenone 50 mg formulation as a test product with Inspra® tablet formulation as a reference product and to evaluate the biocompatibility of these two formulations.
Design
Randomized, single-dose, crossover comparative bioequivalence study of Eplerenone 50 mg tablets of Actover. and Pfizer. in 24 healthy male under fasting.
Settings and conduct
In each period, volunteers will receive a single dose of the treatment in the Noor Research and Development Institute (Tarasht, Tehran). 2 dosing periods will be separated by a 7-day washout period.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
Subjects with normal vital signs.
Exclusion Crieteria: Subject has a history of significant renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder.
Subjects with known allergy to the products tested.
Intervention groups
Intervention group (test):Eplerenone 50 mg tablet, produced by َActover. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Intervention group (Reference): Inspra® tablet, produced by Pfizer is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Main outcome variables
Peak Plasma Concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180620040164N56
Registration date:2024-02-21, 1402/12/02
Registration timing:prospective
Last update:2024-02-21, 1402/12/02
Update count:0
Registration date
2024-02-21, 1402/12/02
Registrant information
Name
Behzad Montaha Sangari
Name of organization / entity
Noor research and educational institute (Tavan)
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 7026
Email address
info@tavaninstitute.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-04-16, 1403/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, single-dose, crossover comparative bioequivalence study of Eplerenone 50 mg tablet of ACTOVERCO and Pfizer Inc. in 24 healthy male under fasting conditions
Public title
bioequivalence study of Eplerenone 50 mg tablet in 24 healthy male under fasting conditions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Subjects with normal vital signs.
Subjects who agree with patient consent form.
Exclusion criteria:
Subject has a history of significant renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder.
Subjects with known allergy to the products tested.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
Age
From 18 years old to 45 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer numbers (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.140
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
During 2 months after intervention
Method of measurement
using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)
Secondary outcomes
1
Description
AUC (Area Under the Concentration-Time Curve)
Timepoint
During 2 months after intervention
Method of measurement
using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)
Intervention groups
1
Description
Intervention group(test):Eplerenone 50 mg tablet, produced by َActover. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Category
Treatment - Drugs
2
Description
Intervention group(Reference): Inspra® tablet, produced by Pfizer is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product.