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Bioequivalence study of Sirolimus 1mg manufactured by Alborz Zagros company versus originator brand in healthy volunteers in fasting condition

Protocol summary

Study aim
Bioequivalence Study of Sirolimus 1mg manufactured by Alborz Zagros company versus originator brand (Rapamune) manufactured by Pfizer company
Design
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization
Settings and conduct
The study is a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be done in Tabriz, Simin bespar teyf gostar company in two periods (72h). The interval between these two periods is 3 weeks. In the first round of the study, the candidates divide into two groups and the first group receives a test tablet and the second group receives a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-28), Informed consent, Age (18-55 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcoholism and Narcoticism, History of allergy to ESirolimus
Intervention groups
Intervention group 1: Rapamune 1mg tablet as a reference Intervention group 2: Sirolimus 1mg manufactured by Alborz zagros as a test
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration, Half-life of drug

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200623047902N11
Registration date: 2021-12-13, 1400/09/22
Registration timing: prospective

Last update: 2021-12-13, 1400/09/22
Update count: 0
Registration date
2021-12-13, 1400/09/22
Registrant information
Name
Elham Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 5196
Email address
ghasemian@zistdaru.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-02, 1401/01/13
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Sirolimus 1mg manufactured by Alborz Zagros company versus originator brand in healthy volunteers in fasting condition
Public title
Bioequivalence study of Sirolimus 1mg tablet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)
Exclusion criteria:
Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Sirolimus
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball and poured into a container and mixed. The balls are then removed randomly from the container. The first 12 no.s are considered as (first sequence: Alborz Zagros's medicine ) and the second 12 no.s are considered as (second sequence: originator brand recipient). The volunteers don't have any information about taking the test drug or brand drug
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Alborz Zagros's Sirolimus and Originator brand's tablets are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
No.58, 8th St. Kooye Nasr (Gisha St.)
City
Tehran
Province
Tehran
Postal code
1446863914
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.TBZMED.REC.1400.830

Health conditions studied

1

Description of health condition studied
This study is performed on healthy volunteers and drug concentration in whole blood is determined.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Drug concentration in blood
Timepoint
0; 0.33, 0.66; 1; 1.33; 1.66, 2; 3; 4; 6; 8; 10; 12; 24; 48; 72h after drug administration
Method of measurement
Liquid chromatography-MASS-MASS (LC- Mas/Mas

Secondary outcomes

1

Description
Time to reach maximum blood concentration
Timepoint
After intervention
Method of measurement
Time to reach the maximum drug concentration is recorded.

2

Description
Extent of absorption
Timepoint
After intervention
Method of measurement
Calculation of area under curve of concentration -time

Intervention groups

1

Description
Intervention group: single dose, 3 oral tablet 1mg (Rapamune) manufactured by Pfizer, as a reference product
Category
Treatment - Drugs

2

Description
Intervention group: Single dose, 3 oral Sirolimus 1mg tablet manufactured by Alborz Zagros company as test product
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Simin Baspar Teyf Gostar Company
Full name of responsible person
Javad Shokri
Street address
No.48, Ferdos Street
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Phone
+98 41 3384 2724
Email
Shokri.j@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz Zagros company
Full name of responsible person
Amir Hossein Zolfaghari
Street address
No.58, 8th St. Kooye Nasr (Gisha St.)
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4163 7000
Email
A.zolfaghari@alborzzagros.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz Zagros 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
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visiting professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.58, 8th St. Kooye Nasr (Gisha St.)
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4163 7000
Email
Ghasemian_elham@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visiting professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.58, 8th St. Kooye Nasr (Gisha St.)
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4163 7000
Email
Ghasemian_elham@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visiting professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.58, 8th St. Kooye Nasr (Gisha St.)
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4163 7000
Email
ghasemian_elham@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
These data are secure between researchers and related industries.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
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