The bioequivalence study of Escitalopram tablet of Alborz Darou company and Ciprolex tablet manufactured by Lundbeck company .
Design
Cross over bioequivalence study
Settings and conduct
Sampling of volunteers is done in Khorazmi Plasma Center in Islamshahr. On the day of sampling, two 10 mg tablets of Escitalopram manufactured by Pars Darou or Lundbeck on two occasions and with a washout period of 14 days, will be administered orally with 240 ml of water to the volunteer. For example, if in the first phase he received the medicine made by Pars Darou company, he will receive the brand medicine two weeks later. In each phase, 5 cc of blood sample will be taken before drug administration and at times 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 24, 48, 72 hours after prescribing the medicine . Two weeks after the start of the study, the volunteer's cooperation in this research ends. The way to cooperate in these three weeks is that the drug is prescribed in the first day and after that 72 hours blood sampling is done at the mentioned times after washout period of two weeks the other drug is administered and blood samples will be taken at the same time
Participants/Inclusion and exclusion criteria
Healthy volunteers , in the age range of 18 to 55 years with a body mass index between 18 and 27 kg per square meter of the body, volunteers who are willing to comply with the requirements of the protocol and provide written informed consent. Non-smokers or smokers who smoke less than 10 cigarettes per day.
Intervention groups
The first group: 12 people who take Alborz Daru tablets
The second group: 12 people who take Lundbeck pills on the same day
Main outcome variables
Plasma concentration and area under the curve of plasma concentration time of test and reference drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220209053979N6
Registration date:2023-02-10, 1401/11/21
Registration timing:prospective
Last update:2023-02-10, 1401/11/21
Update count:0
Registration date
2023-02-10, 1401/11/21
Registrant information
Name
Roya Talari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8880 0892
Email address
talari_r@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-03-05, 1401/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence Study of Escitalopram 10 mg of Pars Darou and Cipralex manufactured by Lundbeck in 24 Healthy Volunteers
Public title
Bioeqivalence study of escitalopram 10 mg tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory tests +/- 10% of normal interval
Without any history of chronic sickness
Exclusion criteria:
History of medicine consumption
Donation of blood sample more than 300 ml within last 30 days
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
17
blood samples wil be taken at 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 24, 48, 72 h after drug administration
Randomization (investigator's opinion)
Randomized
Randomization description
Using the rand option of the Excel software, the candidates are divided into two groups, and half of them will receive numbers 1-12 and the test drug, and the other half will receive numbers 13-24 and will receive the reference drug.
Blinding (investigator's opinion)
Double blinded
Blinding description
The tablets of Pars Darou and Lundbeck are both oval shaped and white in color, so the candidate does not know which company's drug he will receive in each phase of the study. On the other hand, the tubes of the volunteers' samples are also coded, so the analyzer does not know which company's drug he is analyzing, so only the researcher and the prescriber know which company's drug is being prescribed.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science, 16 Azar St.,
City
Tehran
Province
Tehran
Postal code
1417713135
Approval date
2023-02-07, 1401/11/18
Ethics committee reference number
IR. TUMS. TIPS. REC. 1401. 108
Health conditions studied
1
Description of health condition studied
A crossover bioequivalence study in 24 healthy volunteers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma concentration time profile, Maximum plasma concentration, AUC
Plasma concentration is measured by Liquid chromatography with mass spectrometery and pharmacokientic parameters are calculated by excel.
Intervention groups
1
Description
Intervention group: 1: Oral administration of two tablets of citalopram 10 mg manufactured by Pars Darou Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 17 blood samples are taken from each volunteers at certain time. In the second phase (two weeks later) this process is repeated vice verse. That is, these people will take Lundbeck's medicine and give blood samples at 17 time points
Category
Treatment - Drugs
2
Description
Intervention group: 2: Oral administration of two tablets of citalopram 10 mg manufactured by Lundbeck Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 17 blood samples are taken from each volunteers at certain time. In the second phase (two weeks later) this process is repeated vice verse. That is, these people will take Pars Darou medicine and give blood samples at 17 time points
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز پلاسما خوارزمی
Full name of responsible person
Sara Solgi
Street address
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
City
Islamshahr
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Fax
+98 21 5637 8236
Email
Info@kpcir.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pars Darou Company
Full name of responsible person
Fatemeh Zadsaleh
Street address
No. 13, 144 East St., The first square of Tehran Pars,
City
Tehran
Province
Tehran
Postal code
1654713691
Phone
+98 21 7770 4061
Email
info@parsdarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pars Darou Company
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
excutor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
City
Islamshar
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Fax
+98 21 5637 8236
Email
talari_r@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi Plasma Center
Full name of responsible person
Roya Talari
Position
Executer
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
City
Islamshar
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi plasma center
Full name of responsible person
Roya Talari
Position
Excuter
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
City
Islamshar
Province
Tehran
Postal code
3313679886
Phone
+98 21 5669 4726
Email
talari_r@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The bioequivalence study data is completely confidential and according to the contract with Pars Darou Company, it should not be published anywhere.