This study will be performed to compare the pharmacokinetics and invivo parameters of Esomeprazole 40 mg E.C. Capsule formulation as a test product with ®ESOMEP 40 mg E.C Capsule formulation as a reference product and to evaluate the bioequivalence of these two formulations.
Design
Non-blinded, randomized, crossover in vivo bioequivalence study in 24 healthy males under fasting conditions. Block randomization for a treatment sequence of Test/Reference or Reference/Test is used.
Settings and conduct
In each period, volunteers will receive a single dose of the treatment in the Noor Research and Development Institute (Tarasht, Tehran). Two dosing periods will be separated by a 7-day washout period.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Healthy subjects (male) between 18– 55 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. Exclusion Criteria: 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.
Intervention groups
Intervention group 1: Esomeprazole 40 mg E.C. Capsule, produced by Actover Co. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Intervention group 2: ®ESOMEP 40 mg E.C Capsule, produced by HEXAL is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Main outcome variables
Peak Plasma Concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180620040164N92
Registration date:2025-05-21, 1404/02/31
Registration timing:prospective
Last update:2025-05-21, 1404/02/31
Update count:0
Registration date
2025-05-21, 1404/02/31
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
2025-05-30, 1404/03/09
Expected recruitment end date
2025-06-06, 1404/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Esomeprazole 40 mg E.C Capsule of ActoverCo. and ®ESOMEP of HEXAL in 24 healthy subjects under fasting condition
Public title
Comparative in vivo evaluation of 2 formulations of Esomeprazole 40 mg E.C Capsule
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects (male) between 18– 55 years of age.
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:
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.
Subjects who has used any prescription or OTC drugs 14 days prior to the initiation of study and unable to refrain from the concomitant medications.
History of alcohol or drug abuse.
Heavy drinker of caffeine, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
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 55 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 complex, No 2660, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2025-04-28, 1404/02/08
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1404.009
Health conditions studied
1
Description of health condition studied
Gastro-esophageal reflux disease without esophagitis
ICD-10 code
K21.9
ICD-10 code description
Gastro-esophageal reflux disease without esophagitis
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
14 blood samples will be withdrawn pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12
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
14 blood samples will be withdrawn pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12
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: Esomeprazole 40 mg E.C. Capsule, produced by ActoverCo. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Category
Treatment - Drugs
2
Description
Intervention group: Esomep 40 mg E.C. Capsule, produced by HEXAL is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product.