Bioequivalence evaluation of Azithromycin capsule 500 mg of Mahban Pharmaceutical company
Design
Clinical trial with double blinded randomized crossover groups on 24 volunteers
Settings and conduct
The location of the study is Hezareh Sevom futuristic pharmacy Company located in Tehran. The study population is 24 healthy volunteers. Candidates take the test drug for one week and the reference drug for one week, and each candidate does not know what drug he has taken in each week.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
18 to 45 years old, Males and/or non-pregnant, non-lactating females, BMI: 18.5 to 24.9 Kg/m2; A physical examination with no clinically significant finding and laboratory normal tests, not take any chronic or acute medication.
Exclusion criteria:
History of allergic responses , Having significant diseases, Smokers , History or evidence of drug dependence or of alcoholism or of moderate alcohol use, Found positive in urine test for drugs of abuse done before check-in of period;
History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption
Intervention groups
Volunteers will be divided in two groups: at first week, group 1 will receive Azithromycin manufactured by Mahban pharmaceutical company and group 2 will receive Azithromycin manufactured by Pfizer pharmaceutical company . On the second week, group1 will receive Azithromycin manufactured by Pfizer pharmaceutical company and group 2 will receive Azithromycin manufactured by Mahban pharmaceutical company (cross over design)
Main outcome variables
Maximum plasma concentration; area under the curve; the time take to reach maximum plasma concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200625047913N15
Registration date:2024-06-20, 1403/03/31
Registration timing:prospective
Last update:2024-06-20, 1403/03/31
Update count:0
Registration date
2024-06-20, 1403/03/31
Registrant information
Name
Tayebeh Ghari
Name of organization / entity
Hezareh Sevom Futuristic Pharmacist Company
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 2343
Email address
info@hezareh-co.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-20, 1403/05/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence evaluation of Azithromycin Capsule 500 mg of Mahban Pharmaceutical company in comparison with brand drug
Public title
Bioequivalence evaluation of Azithromycin Capsule 500 mg of Mahban Pharmaceutical company
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 45 years old
Sex: Males and/or females
BMI: 18.5 to 24.9 Kg/m2
Being able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent
A physical examination with no clinically significant finding and laboratory normal tests
Exclusion criteria:
Chronic or acute use of any medication at least 1 week before the start of the study
History of diseases affecting the pharmacokinetic processes of the drug
Pregnancy
Lactation
Age
From 18 years old to 45 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Each candidate randomly takes the test or reference drug for one week without being aware of it, and does the opposite in the next week. Volunteers do not know which medication they will receive each week.
Randomization is done in a simple way. Each person is given a number. Then, for each number "test" and "reference" will be considered and written on paper. All the notes are put into the bag and they are taken out one by one until the last number.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Faculty of Paramedicine, next to Milad Tower, Hemet Highway
Intervention group: Azithromycin 500 mg Capsules made by Mahban pharmaceutical company from Iran will be prescribed in the first week at fast condition and blood samples will be drawn in determined intervals.
Category
N/A
2
Description
Control group: Azithromycin 500 mg capsules made by Pfozer pharmaceutical company from Germany will be prescribed in the first week at fast condition and blood samples will be drawn in determined intervals.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hezareh Sevom Futuristic Pharmacist Company
Full name of responsible person
Tayebeh Ghari
Street address
Unit 4, No. 81, Babak Bahrami street, After Zafar street, Vali-e-Asr street
City
Tehran
Province
Tehran
Postal code
1968655815
Phone
+98 21 8865 2343
Fax
+98 21 8820 8678
Email
gharitayebeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hezareh Sevom Futuristic Pharmacist
Full name of responsible person
Tayebeh Ghari
Street address
Unit 4, No. 81, Babak Bahrami street, After Zafar street, Vali-e-Asr street
City
Tehran
Province
Tehran
Postal code
1968655815
Phone
+98 21 8865 2343
Email
info@hezareh-co.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hezareh Sevom Futuristic Pharmacist
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
School of Pharmacy; Alborz University of Medical Sciences
Full name of responsible person
Faranak Salmannejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alborze School of pharmacy, near Bahonar Hospital, Vali-e-asr st, Shora Blv,Karaj.
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Email
salmannejad.f@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborze University of Medical Sciencesو School of Pharmacy
Full name of responsible person
Faranak Salmannejad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alborze School of pharmacy, near Bahonar Hospital, Vali-e-asr st, Shora Blv,Karaj.
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Email
salmannejad.f@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Alborze University of Medical Sciences, School of Pharmacy
Full name of responsible person
Faranak Salmannejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alborze School of pharmacy, near Bahonar Hospital, Vali-e-asr st, Shora lv, Karaj.
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Email
salmannejad.f@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
from 2024
To whom data/document is available
People working in industry and academia
Under which criteria data/document could be used
If the aim is to check the concentration of the Iranian drug in the blood.
From where data/document is obtainable
Sending email to info@hezareh-co.com - Sending fax to 00982188208678 - Calling to 00982188652343 - Responsible person: Tayebeh Ghari
What processes are involved for a request to access data/document
Sending email to info@hezareh-co.com/ request evaluation/sending data