Comparative bioequivalence study of Mesalazine 500 mg ER Capsule of Karen. and PENTASA®of Ferring as reference in 24 healthy male under fasting condition
This study will be performed to compare the pharmacokinetics and invivo parameters of Mesalazine 500 mg ER Capsule formulation as a test product with Mesalazine 500 mg ER Tablet formulation as a reference product and to evaluate the bioequivalence of these two formulations.
Design
Non-blinded, randomized, crossover in vivo bioequivalence study on 24 healthy males under fasting conditions. Block randomization for a treatment sequence of Test/Reference or Reference/Test is used.
Settings and conduct
During each study period, volunteers will receive a single dose intervention (1 or 2) in the Farabi Clinic (Eslamshahr, Tehran). In total, 17 blood samples will be collected during 72 hours post intervention. A 14-day washout interval will separate the study periods.
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.
Exclusion Criteria:
Subjects with known allergy to the products tested or NSAIDs;
Subjects with clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations;
Significant clinical illness within 3 weeks prior to screening.
Intervention groups
Intervention group 1: Mesalazine 500 mg ER Capsule, produced by Karen. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Intervention group 2: Mesalazine 500 mg ER Tablet (PENTASA®), produced by Ferring 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:IRCT20180620040164N46
Registration date:2023-05-31, 1402/03/10
Registration timing:prospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
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
2023-06-23, 1402/04/02
Expected recruitment end date
2023-07-07, 1402/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Mesalazine 500 mg ER Capsule of Karen. and PENTASA®of Ferring as reference in 24 healthy male under fasting condition
Public title
Comparative in vivo evaluation of 2 Mesalazine 500 mg ER Capsule and Mesalazine 500 mg ER Tablet formulations.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects (male) between 20 – 45 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 normal vital signs.
Subjects who agree with patient consent form.
Exclusion criteria:
Subjects with clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations
Subjects with known allergy to the products tested or NSAIDs.
Significant clinical illness within 3 weeks prior to screening.
History of GI surgery or any other surgery within the past 3 months.
History of any significant disease that jeopardize safety of the subject or validity of test results.
History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
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 20 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,School of Pharmacy,Nursing&Midwifery; Shahid Beheshti University of medical science
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.236
Health conditions studied
1
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
14 blood samples will be withdrawn pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours 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
14 blood samples will be withdrawn pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours 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 group1: Mesalazine 500 mg ER Capsule , produced by Karen. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 14-day wash-out period the intervention 2 will be given to these subjects.
Category
Treatment - Drugs
2
Description
Intervention group 2: Mesalazine 500 mg ER Tablet (PENTASA®), produced by Ferring is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 14-day wash-out period the intervention 1 will be given to these subjects.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hakim Farabi Clinic
Full name of responsible person
Ebrahim Siahpoosh
Street address
No. 57, Shemshad alley, in front of Sallor town
City
Tehran
Province
Tehran
Postal code
4635314588
Phone
+98 21 9253 5647
Email
partochem@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karen Pharma and Food Supplement Co.
Full name of responsible person
Zahra Mortazavi
Street address
No: 3, Western Nahid st. Africa Blvd.
City
Tehran
Province
Tehran
Postal code
+98 21 2620 4283
Phone
+98 21 2620 4283
Email
info@karenpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?