Comparative bioequivalence study of Azithromycin 250 mg Tablet of Cosar Pharmaceutical Co. and Zithromax® of Pfizer as reference in 24 healthy male under fasting condition
This study will be performed to compare the pharmacokinetics and invivo parameters of Azithromycin 250 mg Tablet formulation as a test product with Zithromax 250 mg Tablet 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 male under fasting condition.
Settings and conduct
In each period, volunteers will receive a single dose intervention (1 or 2) in the Noor Research & Educational Institute (Tarasht, Tehran).17 blood samples were collected during 72 hours post intervention. A 7-day washout interval separated to study periods.
Participants/Inclusion and exclusion criteria
Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range between 18.5 - 30 kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects with known allergy to the products tested
Intervention groups
Intervention group 1: Azithromycin 250 mg tablet , produced by Cosar pharmaceutical 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: Zithromax 250 mg tablet , produced by Roche 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:IRCT20180620040164N48
Registration date:2023-08-19, 1402/05/28
Registration timing:prospective
Last update:2023-08-19, 1402/05/28
Update count:0
Registration date
2023-08-19, 1402/05/28
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
2023-10-13, 1402/07/21
Expected recruitment end date
2023-10-27, 1402/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Azithromycin 250 mg Tablet of Cosar Pharmaceutical Co. and Zithromax® of Pfizer as reference in 24 healthy male under fasting condition
Public title
Comparative in vivo evaluation of 2 Azithromycin 250 mg Tablet and Zithromax 250 Tablet formulations.
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 between 18.5 - 30 kg/m2.
Subjects that have normal vital signs.
Subjects who agree with patient consent form.
Exclusion criteria:
Known sensitivity to the tested products, hypertension (blood pressure in the standing position after at least 5 minutes of rest, systolic blood pressure greater than or equal to 140 mmHg, and diastolic blood pressure greater than or equal to 90 mmHg).
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
loss of more than 500 milliliters of blood in less than 7 days prior to testing.
Subjects with significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
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's number (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. so it reveals that each volunteer take the medicine in RT or TR order.
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
2023-06-20, 1402/03/30
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.068
Health conditions studied
1
Description of health condition studied
Acute pharyngitis
ICD-10 code
J02
ICD-10 code description
Acute pharyngitis
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 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
17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 11, 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
ntervention group1: Azithromycin 250 mg Tablet , produced by Cosar Pharmaceutical Co. 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: Azithromycin 250 mg Tablet (Zithromax®), produced by Pfizer 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.